FDA · food & medication · last 6 months

The recall log.

Every food and medication enforcement action the FDA has published in the last six months. No account needed — this is public record, made readable.

632 ENFORCEMENT ACTIONS · CLASS I MEANS A REASONABLE PROBABILITY OF SERIOUS HARM

Class IIFoodApr 3, 2026

Walker Honey Co: Raspberry Creamed Honey 671333101322 ¿ These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Ho…

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Product, lots & distribution

Raspberry Creamed Honey 671333101322 ¿ These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey, UPC Code: 671333101322 — Distribution: Texas — Lots/codes: packed after 12/1/2025 — Status: Ongoing (voluntary: firm initiated)

H-0702-2026 · 2,650 units (Total)

Class IIFoodApr 3, 2026

Walker Honey Co: Blackberry Creamed Honey 671333101308 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed H…

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Product, lots & distribution

Blackberry Creamed Honey 671333101308 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey.The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101308 — Distribution: Texas — Lots/codes: packed after 12/1/2025 — Status: Ongoing (voluntary: firm initiated)

H-0703-2026 · 2,650 units (Total)

Class IIFoodApr 3, 2026

Walker Honey Co: Cinnamon Creamed Honey 671333101360 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Hon…

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Product, lots & distribution

Cinnamon Creamed Honey 671333101360 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC: 671333101360 — Distribution: Texas — Lots/codes: packed after 12/1/2025 — Status: Ongoing (voluntary: firm initiated)

H-0704-2026 · 2,650 units (Total)

Class IIFoodApr 3, 2026

Walker Honey Co: Dark Pecan Creamed Honey/Pecan Creamed Honey 671333101407 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline…

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Product, lots & distribution

Dark Pecan Creamed Honey/Pecan Creamed Honey 671333101407 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101407 — Distribution: Texas — Lots/codes: packed after 12/1/2025 — Status: Ongoing (voluntary: firm initiated)

H-0705-2026 · 2,650 units (Total)

Class IIFoodApr 3, 2026

Walker Honey Co: Hatch Creamed Honey 671333101339 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey…

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Product, lots & distribution

Hatch Creamed Honey 671333101339 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101339 — Distribution: Texas — Lots/codes: packed after 12/1/2025 — Status: Ongoing (voluntary: firm initiated)

H-0706-2026 · 2,650 units (Total)

Class IIFoodApr 3, 2026

Walker Honey Co: Lemon Creamed Honey, 671333101353 *These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey…

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Product, lots & distribution

Lemon Creamed Honey, 671333101353 *These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101353 — Distribution: Texas — Lots/codes: packed after 12/1/2025 — Status: Ongoing (voluntary: firm initiated)

H-0707-2026 · 2,650 units (Total)

Class IIFoodApr 3, 2026

Walker Honey Co: Natural Creamed Honey, 671333101377 *These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Hone…

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Product, lots & distribution

Natural Creamed Honey, 671333101377 *These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101377 — Distribution: Texas — Lots/codes: packed after 12/1/2025 — Status: Ongoing (voluntary: firm initiated)

H-0708-2026 · 2,650 units (Total)

Class IIFoodApr 3, 2026

Walker Honey Co: Darkside of the Hive Creamed Honey/Salted Chocolate Creamed Honey 671333101414 *These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were chang…

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Product, lots & distribution

Darkside of the Hive Creamed Honey/Salted Chocolate Creamed Honey 671333101414 *These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101414 — Distribution: Texas — Lots/codes: packed after 12/1/2025 — Status: Ongoing (voluntary: firm initiated)

H-0709-2026 · 2,650 units (Total)

Class IIFoodApr 3, 2026

Walker Honey Co: Hatch Green Chile Creamed Honey 671333101339 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Cr…

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Product, lots & distribution

Hatch Green Chile Creamed Honey 671333101339 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101339 — Distribution: Texas — Lots/codes: packed after 12/1/2025 — Status: Ongoing (voluntary: firm initiated)

H-0710-2026 · 2,650 units (Total)

Class IIFoodApr 3, 2026

Wehah Farms: LUNDBERG FAMILY FAMRS WHITE RICE JASMINE NET WT 32 OZ (2 lb) 907 g Manufactured and Distributed by: Lundberg Family Farms Richvale, CA 95974 UPC: 073416040281

Potential contamination with foreign materials.

Product, lots & distribution

LUNDBERG FAMILY FAMRS WHITE RICE JASMINE NET WT 32 OZ (2 lb) 907 g Manufactured and Distributed by: Lundberg Family Farms Richvale, CA 95974 UPC: 073416040281 — Distribution: U.S. States: CA, CT, FL, IL, NC, NH, NY, PA, TN, VT, WA, WI. Foreign distribution: None — Lots/codes: Lot, Best Before: 260201MA, 01FEB2027; 260202MA, 02FEB2027. — Status: Ongoing (voluntary: firm initiated)

H-0767-2026 · 27,324 packages (6 packages/case; 4,554 cases)

Class IIFoodApr 3, 2026

Galaxy RG Corp: Brazo Gitano [image] Caramel Sweet Roll The Original, Net Wt. 24 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container.…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Brazo Gitano [image] Caramel Sweet Roll The Original, Net Wt. 24 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 882479852232 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0915-2026 · 2,273 (24-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Jumbo Brazo Gitano Caramelo [image] Jumbo Caramel Roll The Original, Net Wt. 40 oz, packaged in a rigid plastic clamshell container with a transparent dome lid, one unit per container…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Jumbo Brazo Gitano Caramelo [image] Jumbo Caramel Roll The Original, Net Wt. 40 oz, packaged in a rigid plastic clamshell container with a transparent dome lid, one unit per container. KEEP REFRIGERATED. UPC 824790852645 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0916-2026 · 1,116 (40-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Napolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852256

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Napolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852256 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0917-2026 · 5,960 (22-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Jumbo Napolitano [image] Jumbo Neapolitan, Net Wt. 26 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRI…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Jumbo Napolitano [image] Jumbo Neapolitan, Net Wt. 26 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790853086 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0918-2026 · 2,598 (26-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Rollitos de Guava [image] Guava Rolls The Original, Net Wt. 15 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 8247…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Rollitos de Guava [image] Guava Rolls The Original, Net Wt. 15 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852454 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0919-2026 · 7,856 (15-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Rollitos de DulceLeche [image] Caramel Rolls The Original, Net Wt. 15 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. U…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Rollitos de DulceLeche [image] Caramel Rolls The Original, Net Wt. 15 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852454 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0920-2026 · 1,334 (15-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Capuchino [image] Syrup Cone Cake The Original, Net Wt. 13 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 82479085…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Capuchino [image] Syrup Cone Cake The Original, Net Wt. 13 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852119 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0921-2026 · 3,028 (13-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Cake de Capuchino [image] Capuchino Cake The Original, Net Wt. 63 oz, packaged in a transparent and rigid plastic clamshell container with a transparent dome lid and tray base, one un…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Cake de Capuchino [image] Capuchino Cake The Original, Net Wt. 63 oz, packaged in a transparent and rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790850375 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0922-2026 · 3,786 (63-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Cake de Coco [image] Coconut Cake The Original, Net Wt. 47 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Cake de Coco [image] Coconut Cake The Original, Net Wt. 47 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790852775 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0923-2026 · 241 (47-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Cake de Fresa y Chocolate [image] Stawberry & Chocolate Cake The Original, Net Wt. 48 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, on…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Cake de Fresa y Chocolate [image] Stawberry & Chocolate Cake The Original, Net Wt. 48 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790852980 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0924-2026 · 190 (48-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Cake de Guayaba [image] Guava Cake The Original, Net Wt. 47 oz, packaged in a plastic container, one unit per container. KEEP REFRIGERATED. UPC 824790852782

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Cake de Guayaba [image] Guava Cake The Original, Net Wt. 47 oz, packaged in a plastic container, one unit per container. KEEP REFRIGERATED. UPC 824790852782 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0925-2026 · 311 (47-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Cake de Mango [image] Mango Cake The Original, Net Wt. 47 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP R…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Cake de Mango [image] Mango Cake The Original, Net Wt. 47 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 824790852805 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0926-2026 · 257 (47-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Tiramisu [image] Cofee Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790850320

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Tiramisu [image] Cofee Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790850320 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0927-2026 · 221 (30-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Marquesita de Guava [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGE…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Marquesita de Guava [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0928-2026 · 1,316 (16-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Marquesita de Mango [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGE…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Marquesita de Mango [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0929-2026 · 442 (16-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Marquesita de Fresa [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGE…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Marquesita de Fresa [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0930-2026 · 629 (16-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Marquesita de Dulceleche [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP RE…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Marquesita de Dulceleche [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0931-2026 · 877 (16-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Marquesita de Chocolate y Vainilla [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per containe…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Marquesita de Chocolate y Vainilla [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852706 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0932-2026 · 809 (16-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Cheesecake de Dulce de Leche [image] Caramel Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFR…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Cheesecake de Dulce de Leche [image] Caramel Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852829 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0933-2026 · 498 (26-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Cheesecake de Mango [image] Mango Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. U…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Cheesecake de Mango [image] Mango Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852836 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0934-2026 · 93 (26-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Cheesecake de Fresa [image] Strawberry Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERAT…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Cheesecake de Fresa [image] Strawberry Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852843 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0935-2026 · 149 (26-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Cheesecake de Guava [image] Guava Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. U…

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Cheesecake de Guava [image] Guava Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790853116 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0936-2026 · 375 (26-oz) units

Class IIFoodApr 3, 2026

Galaxy RG Corp: Flan Cake [image] Custard Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852959

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

Product, lots & distribution

Flan Cake [image] Custard Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell container, one unit per container. KEEP REFRIGERATED. UPC 824790852959 — Distribution: FL and TX. — Lots/codes: Expiration Date: From 04/03/2026 to 05/03/2026 Lot#034320462, 034320562, 034320662, 034320962, 034321062, 034321162, 034321262, 034321362, 034321662, 034321762, 034321862, 034321962, 034322062, 034322362, 034322462, 034322562, 034322662, 034322762, 034323062, 034323162, 044320162, 044320262, 044320362 — Status: Ongoing (voluntary: firm initiated)

H-0937-2026 · 423 (30-oz) units

Class IIMedicationApr 2, 2026

B BRAUN MEDICAL INC: Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Product, lots & distribution

Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60. — Distribution: US Nationwide. — Lots/codes: Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028. — Status: Ongoing (voluntary: firm initiated)

D-0495-2026 · 24,928 bags

Class IIMedicationApr 2, 2026

B BRAUN MEDICAL INC: DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Product, lots & distribution

DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50. — Distribution: US Nationwide. — Lots/codes: Lot # J5H166, J5H167, Exp Date: 30NOV2026. — Status: Ongoing (voluntary: firm initiated)

D-0496-2026 · 17,124 bags

Class IIMedicationApr 2, 2026

B BRAUN MEDICAL INC: 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Product, lots & distribution

0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60. — Distribution: US Nationwide. — Lots/codes: Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028. — Status: Ongoing (voluntary: firm initiated)

D-0497-2026 · 124,244 bags

Class IIMedicationApr 2, 2026

B BRAUN MEDICAL INC: LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Product, lots & distribution

LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60. — Distribution: US Nationwide. — Lots/codes: Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028. — Status: Ongoing (voluntary: firm initiated)

D-0498-2026 · 54,540 bags

Class IIMedicationApr 2, 2026

Huons Co., Ltd.: Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-000…

Lack of Assurance of Sterility

Product, lots & distribution

Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton) — Distribution: USA Nationwide. — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)

D-0529-2026 · 33,599,925 ampules and 23658125 vials

Class IIMedicationApr 2, 2026

Huons Co., Ltd.: Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheong…

Lack of Assurance of Sterility

Product, lots & distribution

Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules) — Distribution: USA Nationwide. — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)

D-0530-2026 · 3,260,170 ampules

Class IIMedicationApr 2, 2026

Huons Co., Ltd.: 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd…

Lack of Assurance of Sterility

Product, lots & distribution

0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1. — Distribution: USA Nationwide. — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)

D-0531-2026 · 7,120,750 ampules

Class IIMedicationApr 2, 2026

Huons Co., Ltd.: Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, ND…

Lack of Assurance of Sterility

Product, lots & distribution

Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton) — Distribution: USA Nationwide. — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)

D-0532-2026 · N/A

Class IIFoodApr 2, 2026

F&S Fresh Foods, Inc.: ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwich, perishable, Keep Refrigerated, plastic clamshell, net wt. 10 oz, UPC 8 26766 25036 3. Distributed By F&S Fresh Foods Vin…

Undeclared sesame. Sandwich contains visible sesame but label does not declare sesame.

Product, lots & distribution

ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwich, perishable, Keep Refrigerated, plastic clamshell, net wt. 10 oz, UPC 8 26766 25036 3. Distributed By F&S Fresh Foods Vineland, NJ 08360. Label declares CONTAINS EGG, MILK, SOY, WHEAT. — Distribution: distributed in OR — Lots/codes: Best if Used By: 04/06/26 Lot: FSNW 089 Manufacturing location (Clackamas, OR) Julian Date — Status: Terminated (voluntary: firm initiated)

H-0659-2026 · 325 units distributed (only 27 units were mis-labeled)

Class IIMedicationApr 1, 2026

International Medication Systems Ltd.: EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Compa…

Lack of Assurance of Sterility

Product, lots & distribution

EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1 — Distribution: U.S. Nationwide — Lots/codes: Lot Number: EA038A5, Expiration Date: 08/2026. — Status: Ongoing (voluntary: firm initiated)

D-0483-2026 · 81,520 units

Class IIMedicationApr 1, 2026

Island Kinetics, Inc. d.b.a. CoValence Laboratories: Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.

Failed Stability Specifications

Product, lots & distribution

Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9. — Distribution: U.S. Nationwide — Lots/codes: Lot#: 4228D2, 4229D1, Exp.: 07/31/2026 Lot#: 5147D2, Exp.: 04/30/2027 — Status: Ongoing (voluntary: firm initiated)

D-0487-2026 · 28,163 bottles

Class IIMedicationApr 1, 2026

Wells Pharma of Houston LLC: Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03

cGMP deviations.

Product, lots & distribution

Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03 — Distribution: U.S. Nationwide. — Lots/codes: 120325122032719, Exp Date 04/03/2026, 120425122032734 Exp Date 04/04/2026, 120425122032735, Exp Date 04/04/2026, 120925122032781, Exp Date 04/10/2026, 010626122030010, Exp Date, 05/08/2026, 010626122030009, Exp Date 05/08/2026, 010826122030031, Exp Date 05/13/2026, 010826122030032, Exp Date 05/13/2026, 011326122030072, Exp Date 05/15/2026, 011326122030071, Exp Date 05/15/2026, 011626122030107, Exp Date 05/20/2026, 011626122030106, Exp Date 05/20/2026, 011926122030118, Exp. Date, 05/21/2026, 011926122030119, Exp Date, 05/21/2026, 012726122030171, Exp Date, 05/29/2026, 012726122030170, Exp Date… — Status: Ongoing (voluntary: firm initiated)

D-0502-2026 · 13,070 IV Bags

Class IIMedicationApr 1, 2026

Wells Pharma of Houston LLC: fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.

cGMP deviations.

Product, lots & distribution

fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02. — Distribution: U.S. Nationwide. — Lots/codes: 120925202022769, Expiration Date 04/09/2026, 123125202022883, Expiration Date 05/05/2026, 123125202022884, Expiration Date 05/05/2026 011226202020057, Expiration Date 05/14/2026, 011226202020058, Expiration Date 05/14/2026, 011626202020110, Expiration Date 05/20/2026 012726202020156, Expiration Date 05/28/2026. 012726202020161, Expiration Date 05/28/2026 020226202020195, Expiration Date 06/04/2026 021826202020386, Expiration Date 06/20/2026 022026202020417, Expiration Date 06/24/2026 022026202020424 Expiration Date 06/24/2026 — Status: Ongoing (voluntary: firm initiated)

D-0503-2026 · 4,030 IV Bags

Class IIMedicationApr 1, 2026

Wells Pharma of Houston LLC: fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.

cGMP deviations.

Product, lots & distribution

fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03. — Distribution: U.S. Nationwide. — Lots/codes: 120125202032701, Exp Date 04/01/2026; 122625202032857, Exp Date 04/25/2026; 122625202032862, Exp Date 04/28/2026, 122625202032863. Exp Date 04/28/2026; 122625202032864, Exp Date 04/28/2026; 122625202032865, Exp Date 04/28/2026, 011226202030062, Exp Date 05/14/2026, 011326202030776, Exp Date 05/15/2026; 011326202030077, Exp Date 05/15/2026, 011626202030111, Exp Date 05/20/2026, 011926202030122, Exp Date 05/21/2026; 011926202030123, Exp Date 05/21/2026, 012726202030159, Exp Date 05/28/2026, 020226202030200, Exp Date 06/04/2026, 020326202030216, Exp Date 06/05/2026, 020426202030234, Exp Date 06/… — Status: Ongoing (voluntary: firm initiated)

D-0504-2026 · 2940 IV Bags

Class IIMedicationApr 1, 2026

Wells Pharma of Houston LLC: fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.

cGMP deviations.

Product, lots & distribution

fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25. — Distribution: U.S. Nationwide. — Lots/codes: Lot 011226204250063, Exp Date 05/14/2026 — Status: Ongoing (voluntary: firm initiated)

D-0505-2026 · 50 syringes

Class IIMedicationApr 1, 2026

Wells Pharma of Houston LLC: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.

cGMP deviations.

Product, lots & distribution

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65. — Distribution: U.S. Nationwide. — Lots/codes: Lot 022326203650432; Exp Date 06/25/2026 — Status: Ongoing (voluntary: firm initiated)

D-0506-2026 · 150 syringes

Class IIMedicationApr 1, 2026

Wells Pharma of Houston LLC: Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.

cGMP deviations.

Product, lots & distribution

Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31. — Distribution: U.S. Nationwide. — Lots/codes: 120925302312764, Exp Date 04/09/2026, 123125302312879 Exp Date, 05/05/2026, 123125302312880, Exp Date 05/05/2026, 010226302310003, Exp Date 05/06/2026, 010626302310007, Exp Date 05/08/2026, 010626302310008, Exp Date 05/08/2026 020426302310243, Exp Date 06/06/2026. — Status: Ongoing (voluntary: firm initiated)

D-0507-2026 · 4975 syringes

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