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 IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428,…

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-595-23. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)

D-0561-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COMPANY, ANKENY, IA 50521, UPC: 0 98437 24361 9.

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COMPANY, ANKENY, IA 50521, UPC: 0 98437 24361 9. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)

D-0562-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: 24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-ELEVEN, IRVING, TX 75063, UPC 0 5254863573 2.

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-ELEVEN, IRVING, TX 75063, UPC 0 5254863573 2. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276119, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)

D-0563-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc.,Tewksbury, Mass 01875, UPC 0 49705 83149 6.

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc.,Tewksbury, Mass 01875, UPC 0 49705 83149 6. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)

D-0564-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80.

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, 1276119, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)

D-0565-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23.

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716259, Exp 3/31/2029. — Status: Ongoing (voluntary: firm initiated)

D-0566-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8.

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, Exp 1/31/2029. — Status: Ongoing (voluntary: firm initiated)

D-0567-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA.…

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., NDC 55319-171-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)

D-0568-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA.…

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., UP: 0 32251-92282-4. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716259, expires: MAR 2029. — Status: Ongoing (voluntary: firm initiated)

D-0569-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1.

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)

D-0570-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1.

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276119, expires: Jan 2029. — Status: Ongoing (voluntary: firm initiated)

D-0571-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5.

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)

D-0572-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC…

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC 37808-136-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)

D-0573-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22.

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)

D-0574-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68.

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)

D-0575-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22.

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)

D-0576-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68.

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)

D-0577-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-…

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276119, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)

D-0578-2026

Class IIMedicationMay 28, 2026

Guardian Drug Co. Inc.: TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129…

Presence of foreign substance: small metallic particles in chewable tablets.

Product, lots & distribution

TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)

D-0579-2026

Class IIMedicationMay 28, 2026

Ajanta Pharma USA Inc: Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120…

CGMP Deviations

Product, lots & distribution

Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04. — Distribution: U.S. Nationwide — Lots/codes: Lot # PA02216; Exp. 12/2029 — Status: Ongoing (voluntary: firm initiated)

D-0611-2026 · 3648 bottles

Class IIMedicationMay 28, 2026

CareFusion 213, LLC: BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, T…

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Product, lots & distribution

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31. — Distribution: Nationwide inthe USA, as well as other foreign distribution. — Lots/codes: Lot # 3201277, Exp Date: 06/30/2026; Lot # 3213912, 3214206, 3214914, 3215710, 3227485, Exp Date: 07/31/2026; Lot # 3234036, 3234037, 3236460, 3237244, 3243095, 3263576, 3263580, 3264318, Exp Date: 08/31/2026; Lot # 3266655, 3266657, 3270586, 3278714, 3279949, 3282215, 3282956, Exp Date: 09/30/2026; Lot # 3299094, 3299684, 3302529, 3301463, 3309836, 3310556, 3312230, 3314562, Exp Date: 10/31/2026; Lot # 3321426, Exp Date: 11/30/2026; Lot # 3350974, 3352268, 3354120, 3354127, 3356911, 4003299, 4013168, Exp Date: 12/31/2026; Lot # 4023898, 4024208, 4024754, 4030686, 4031689, 4032182, 4032183, 4… — Status: Ongoing (voluntary: firm initiated)

D-0622-2026 · N/A

Class IIMedicationMay 28, 2026

CareFusion 213, LLC: BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El…

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Product, lots & distribution

BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30. — Distribution: Nationwide inthe USA, as well as other foreign distribution. — Lots/codes: Lot # 3143780, 3151595, 3152898, 3152906, 3157235, 3158139, 3159803, 3166919, 3167620, 3191056, Exp Date: 05/31/2026; Lot # 3171115, 3172853, 3177820, 3193968, 3194750, 3199123, 3201195, 3206618, 3212202, 3213819, 3214876, Exp Date: 06/30/2026; Lot # 3222170, 3226846, 3228153, 3229867, 3228293, 3243337, Exp Date: 07/31/2026; Lot # 3230424, 3234042, 3240990, 3244469, 3249346, 3251278, 3254346, 3255678, 3258407, Exp Date: 08/31/2026; Lot # 3261058, 3263492, 3264573, 3268341, 3270418, 3275533, 3276460, 3278683, 3283037, 3284107, 3292960, 3292965, Exp Date: 09/30/2026; Lot # 3286221, 3290240, 329… — Status: Ongoing (voluntary: firm initiated)

D-0623-2026 · N/A

Class IIFoodMay 28, 2026

Specialty Bakers, LLC: Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximately 23.67 grams. 1package is 142 grams. 1 package has 1 plastic tray which holds 6 dess…

Undeclared Allergen (Soy)

Product, lots & distribution

Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximately 23.67 grams. 1package is 142 grams. 1 package has 1 plastic tray which holds 6 desserts shells. Plastic is wrapped around 1 tray. 24 packs/Case. Frozen — Distribution: The adulterated product was distributed to the following states, Pennsylvania. — Lots/codes: Lot Number: 968674 — Status: Ongoing (voluntary: firm initiated)

H-1145-2026 · 449 cases

Class IIFoodMay 28, 2026

Wise Foods Inc: Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case,

The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3.

Product, lots & distribution

Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case, — Distribution: The adulterated product was distributed to the following States: NC, VA, PA, NJ, NY, SC, FL — Lots/codes: UPC: 041262288874 Internal production number: 4228887 Lot Codes (expiration date): AUG0326, AUG1026, AUG1726 — Status: Ongoing (voluntary: firm initiated)

H-1146-2026 · 490 cases

Class IIMedicationMay 27, 2026

Lannett Company Inc.: Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.

Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.

Product, lots & distribution

Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 25282724A, Exp. Date 2027/01 — Status: Ongoing (voluntary: firm initiated)

D-0584-2026 · 3984 bottles

Class IIMedicationMay 27, 2026

Glenmark Pharmaceuticals Inc., USA: Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day re…

Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

Product, lots & distribution

Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29 — Distribution: USA Nationwide. — Lots/codes: Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027 — Status: Ongoing (voluntary: firm initiated)

D-0588-2026

Class IIMedicationMay 27, 2026

Ajanta Pharma USA Inc: Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.

Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.

Product, lots & distribution

Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03. — Distribution: U.S. Nationwide — Lots/codes: Lot: PA00805, expires: 01/31/2029 — Status: Ongoing (voluntary: firm initiated)

D-0594-2026 · 6,143 bottles

Class IIFoodMay 26, 2026

Nutricia North America: functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 57858 00453 3, package UPC 8 57858 00450 2

Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.

Product, lots & distribution

functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 57858 00453 3, package UPC 8 57858 00450 2 — Distribution: Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,… — Lots/codes: 24 count case with BEST IF USED BY DATES up to and including March 15, 2028 12 count package BEST IF USED BY DATES up to and including October 7, 2027 — Status: Ongoing (voluntary: firm initiated)

H-1152-2026 · 1,363cs/12/12oz pouches + 16,298cs/24/12oz pouches

Class IIFoodMay 26, 2026

Nutricia North America: functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY COMPLETE PLANT BASED NUTRITION NET WT. 12 OZ (341g) case UPC 8 57858 00445 8,…

Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.

Product, lots & distribution

functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY COMPLETE PLANT BASED NUTRITION NET WT. 12 OZ (341g) case UPC 8 57858 00445 8, package UPC 8 57858 00447 2 — Distribution: Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,… — Lots/codes: 24 count case with BEST IF USED BY DATES up to and including April 14, 2028 12 count package BEST IF USED BY DATES up to and including February 19, 2028 — Status: Ongoing (voluntary: firm initiated)

H-1153-2026 · 2,050cs/12/12oz pouches + 55,310cs/24/12oz pouches

Class IIMedicationMay 22, 2026

Zep Inc: Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, N…

Microbial contamination of sterile products

Product, lots & distribution

Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85. — Distribution: US Nationwide. — Lots/codes: Batch # E2612116, Exp Date: April 2029. — Status: Ongoing (voluntary: firm initiated)

D-0586-2026 · 5 drums

Class IIMedicationMay 22, 2026

SUN PHARMACEUTICAL INDUSTRIES INC: Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by:…

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

Product, lots & distribution

Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-762-10 — Distribution: Nationwide within the United States — Lots/codes: Lot #: AD93852, Exp Date: 06/2027. — Status: Ongoing (voluntary: firm initiated)

D-0598-2026

Class IIMedicationMay 22, 2026

SUN PHARMACEUTICAL INDUSTRIES INC: Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by:…

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

Product, lots & distribution

Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10 — Distribution: Nationwide within the United States — Lots/codes: Lot #: AE11393, Exp Date: 10/2027. — Status: Ongoing (voluntary: firm initiated)

D-0599-2026

Class IIFoodMay 22, 2026

University of California Health Milk Bank: 001165: Standard Pasteurized Donor Human Milk; 100 mL bottles 001198: Pediatric Pasteurized Donor Human Milk; 200 mL bottles No UPC

Product is potentially contaminated with foreign material (plastic particles).

Product, lots & distribution

001165: Standard Pasteurized Donor Human Milk; 100 mL bottles 001198: Pediatric Pasteurized Donor Human Milk; 200 mL bottles No UPC — Distribution: Product is distributed to medical facilities and direct to consumer through medical facility. All facilities and consumers are located in CA. — Lots/codes: Expiration dates: 001165: 8/4/2026 001198: 10/31/2026 Lot Codes: 001165-1, 001165-2, 001165-3, 001165-4, 001165-5, 001165-6, 001165-7, 001165-8 001198-, 001198-2, 00198-3, 001198-4, 001198-5 — Status: Terminated (voluntary: firm initiated)

H-0948-2026 · 60 liters (441 bottles) total

Class IIFoodMay 22, 2026

Boichik Bagels, Inc.: boichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate,…

Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.

Product, lots & distribution

boichik bagels Whitefish Salad Ingredients: Smoked whitefish, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate, calcium disodium edta, natural flavors), pickle juice, mustard, chives, black pepper. Contains: Fish — Distribution: Domestic: CA Foreign: Not applicable — Lots/codes: Sell By: 05-22-26, 05-23-26, 05-24-26, 05-25-26, 05-27-26, 05-28-26, 05-29-26, 05-30-26, 05-31-26, 06-01-26, 06-02-26, 06-03-26, 06-04-26 — Status: Ongoing (voluntary: firm initiated)

H-1131-2026 · 167 containers

Class IIFoodMay 22, 2026

Boichik Bagels, Inc.: boichik bagles Tuna Salad Ingredients: albacore tuna, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate, calcium…

Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.

Product, lots & distribution

boichik bagles Tuna Salad Ingredients: albacore tuna, mayonnaise (soybean oil, water, whole eggs and egg yolks, distilled vinegar, salt, sugar, lemon juice concentrate, calcium disodium edta, natural flavors), pickle juice, mustard, chives, black pepper. Contains: Fish — Distribution: Domestic: CA Foreign: Not applicable — Lots/codes: Sell By: 05-22-26, 05-23-26, 05-24-26, 05-25-26, 05-27-26, 05-28-26, 05-29-26, 05-30-26, 05-31-26, 06-01-26, 06-02-26, 06-03-26, 06-04-26 — Status: Ongoing (voluntary: firm initiated)

H-1132-2026 · 164 containers

Class IIFoodMay 22, 2026

Boichik Bagels, Inc.: boichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g Ingredients: Organic wheat flour ... Contains Wheat Topped flavors may additionally cont…

Undeclared allergen, sesame.

Product, lots & distribution

boichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g Ingredients: Organic wheat flour ... Contains Wheat Topped flavors may additionally contain ... sesame seeds ... Best by SE 26 26 UPC: 850016588067 — Distribution: Domestic: CA Foreign: Not applicable — Lots/codes: Best by: MAY 25 26, JUN 20 26, JUL 15 26, AUG 23 26, SE 26 26 — Status: Ongoing (voluntary: firm initiated)

H-1133-2026 · 426 packages (6 bagels/package)

Class IIMedicationMay 21, 2026

Keystone Industries: Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-000…

Defective container:may contain bottles with incomplete seals

Product, lots & distribution

Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3. — Distribution: Nationwide in the USA — Lots/codes: BNZ-001917, Exp 04/01/2029 — Status: Ongoing (voluntary: firm initiated)

D-0600-2026 · 900 units

Class IIMedicationMay 21, 2026

Keystone Industries: Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le…

Defective container:may contain bottles with incomplete seals

Product, lots & distribution

Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30. — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, EXP 04/15/2029 — Status: Ongoing (voluntary: firm initiated)

D-0601-2026 · 150 units

Class IIMedicationMay 21, 2026

Keystone Industries: DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Fran…

Defective container:may contain bottles with incomplete seals

Product, lots & distribution

DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30 — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, EXP 04/15/2029 — Status: Ongoing (voluntary: firm initiated)

D-0602-2026 · 150 units

Class IIMedicationMay 21, 2026

Keystone Industries: Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30

Defective container:may contain bottles with incomplete seals

Product, lots & distribution

Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30 — Distribution: Nationwide in the USA — Lots/codes: BNZ-001917, Exp 04/15/2029 — Status: Ongoing (voluntary: firm initiated)

D-0603-2026 · 150 units

Class IIMedicationMay 21, 2026

Keystone Industries: Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30

Defective container:may contain bottles with incomplete seals

Product, lots & distribution

Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30 — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, Exp 04/15/2029 — Status: Ongoing (voluntary: firm initiated)

D-0604-2026 · 450 units

Class IIMedicationMay 21, 2026

Keystone Industries: PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001…

Defective container:may contain bottles with incomplete seals

Product, lots & distribution

PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30 — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, EXP 04/15/2029 — Status: Ongoing (voluntary: firm initiated)

D-0605-2026 · 450 units

Class IIMedicationMay 21, 2026

Keystone Industries: safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA,…

Defective container:may contain bottles with incomplete seals

Product, lots & distribution

safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1. — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, Exp 04/15/2029 — Status: Ongoing (voluntary: firm initiated)

D-0606-2026 · 150 units

Class IIFoodMay 21, 2026

Fairhope Roasting Company: Fairhope Roasting Company Cold Brew Coffee Concentrate, packaged in 1-gallon plastic jugs, UPC 852236006062, for food service only

Product requires refrigeration but the label is missing a "Keep Refrigerated" statement

Product, lots & distribution

Fairhope Roasting Company Cold Brew Coffee Concentrate, packaged in 1-gallon plastic jugs, UPC 852236006062, for food service only — Distribution: Product distributed in AL for food service only — Lots/codes: Batch Number: 05/11/26, Expiration Date: 09/09/26 Batch Number: 05/12/26, Expiration Date: 09/10/26 Batch Number: 05/13/26, Expiration Date: 09/11/26 Batch Number: 05/14/26, Expiration Date: 09/12/26 — Status: Terminated (voluntary: firm initiated)

H-0951-2026 · 15 gallons

Class IIFoodMay 21, 2026

Alb-USA Enterprises Inc: El David Gelee, Bonbons with fruits Soft & Juicy, 400g. Packaged in decorated paperboard box and covered entirely in transparent, flexible plastic wrap. (20 bonbon pieces per…

Undeclared colors (FD&C Yellow 5 and FD&C Red 40).

Product, lots & distribution

El David Gelee, Bonbons with fruits Soft & Juicy, 400g. Packaged in decorated paperboard box and covered entirely in transparent, flexible plastic wrap. (20 bonbon pieces per 400g box). UPC 5304000050757 — Distribution: NY, NJ — Lots/codes: Expiration Date(s): 12.05.2027 — Status: Ongoing (voluntary: firm initiated)

H-1110-2026 · 15 (400g) boxed units (20 pieces/box)

Class IIMedicationMay 19, 2026

Shimoga Chemicals: Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, S…

cGMP deviations

Product, lots & distribution

Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India. — Distribution: CA & FL only — Lots/codes: Lot #: a) CC/004/24-25, Exp Date September 2029; CC0032526, Exp. Date August 2030 b) CC0442526, Exp. Date Aug 2030; CC/005/24-25, Exp. Date November 2029 c) CC0032526, Exp. Date August 2030; CC/009/24-25, Exp. Date January 2030;CC/005/24-25, Exp. Date November 2029. — Status: Ongoing (voluntary: firm initiated)

D-0691-2026 · N/A

Class IIFoodMay 19, 2026

Rich Products Corp: Farm Rich Pizza Cheese Crunchers

May contain metal pieces

Product, lots & distribution

Farm Rich Pizza Cheese Crunchers — Distribution: TX, MD, MO, NY, AR, FL, NJ, TN, AL, OH, KY, PA, NC, SC, KS, MI, IA, IN, WI, GA, CA — Lots/codes: Lot/Unit Numbers: 003029976 Best by 7/30/27 UPC Codes: 041322652256 — Status: Ongoing (voluntary: firm initiated)

H-0912-2026 · 6408 cases (160,200 lbs.)

Class IIMedicationMay 18, 2026

IntegraDose Compounding Services LLC: Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.

Subpotent Drug

Product, lots & distribution

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1. — Distribution: U.S.A. Nationwide — Lots/codes: Lot#: 20260327VAS-3, BUD: 05/26/2026; 20260320VAS-3, BUD: 05/19/2026. — Status: Ongoing (voluntary: firm initiated)

D-0593-2026 · 287 units

Class IIMedicationMay 18, 2026

PReye LLC: PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO

Lack of Assurance of Sterility

Product, lots & distribution

PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO — Distribution: CO — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)

D-0621-2026 · approximate 50 to 60 bottles

Class IIFoodMay 18, 2026

International Food Products Corporation: Legacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags

Product tested positive for Salmonella

Product, lots & distribution

Legacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags — Distribution: TX, TN, OK — Lots/codes: Lot 26121A6A Item #502574 Use by 2027-05-04 — Status: Ongoing (voluntary: firm initiated)

H-1076-2026 · 546 bags

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