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)
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)
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)
Class IFoodMay 22, 2026
Total Nutrition Inc: 1. TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules (120 count) 2. Doctor s Pride Complete Green Superfood Ultra Potent Moringa 10,000 mg (120 capsules)
Product may be contaminated with Salmonella.
Product, lots & distribution
1. TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules (120 count) 2. Doctor s Pride Complete Green Superfood Ultra Potent Moringa 10,000 mg (120 capsules) — Distribution: Nationwide — Lots/codes: 1. Lot: 2507199 Exp. 09/2027 Lot: 2512-304 Exp. 02/2028 Lot: 2793 Exp. 02/2028 Lot: 2748 Exp. 07/2027 ASIN: B0DBRDPBDT, SKU: AB8047, UPC: 095234280472, FNSKU: X004C9XHAL 2. Lot: 2507199 Exp. 09/2027 Lot: 2748 Exp. 07/2027 UPC: 095234698734; SKU: AB9873 — Status: Ongoing (voluntary: firm initiated)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Class IFoodMay 20, 2026
Hometown Food Company: Birch Benders Sweet Potato Pancake and Waffle Mix 12oz bag, UPC 8 1000156076 8, 6 bags per case
Undeclared egg
Product, lots & distribution
Birch Benders Sweet Potato Pancake and Waffle Mix 12oz bag, UPC 8 1000156076 8, 6 bags per case — Distribution: AZ CA CO CT FL GA IA IL IN KY MD NH NJ NV NY OR PA TX WA WI — Lots/codes: Lot 5 265 Best if Used By MAR 24 2027 — Status: Ongoing (voluntary: firm initiated)
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)
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)
Class IIIFoodMay 19, 2026
Refresqueria Estrella Inc.: ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic Bottles packed in cases of…
Undeclared FD&C Red 40
Product, lots & distribution
ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic Bottles packed in cases of 25 bottles. KEEP REFRIGIRATED. — Distribution: Puerto Rico distribution only. — Lots/codes: May Production Lot Code:12426, 13126, 13426. 4/8/2026 Expiration Date: 4/8/2026, 5/8/2026, 6/8/2026, 11/8/2026, 11/8/2026, 14-08-2026, 14-08-2026 April Production Lot Code: 9226, 9626, 9826, 9926, 10326, 10626, 11026, 11126, 11326, 11826, 11926, 12026 Expiration Date:2/7/2026, 6/7/2026, 8/7/2026, 9/7/2026, 13-07-2026, 16-07-2026, 16-07-2026, 20-07-2026, 21-07-2026, 22-07-2026, 23-07-2026, 23-07-2026, 28-07-2026, 29-07-2026 30-07-2026 March Production Lot Code:6126, 6426, 7026, 9926, 8326, 8226, 8626, 9026 Expiration Date: 2/6/2026, 5/6/2026, 11/6/2026, 20-06-2026, 23-06-2026, 24-06-2026, 27-0… — Status: Ongoing (voluntary: firm initiated)
Class IFoodMay 19, 2026
Kettle Cuisine, LLC: Individual Unit Label (both lid and front of cup): Whole Foods Market Kitchens Minestrone Soup, VEGETARIAN NET WT 24 OZ (1 Lb 8OZ) 680g. Case Label: Whole Foods Global Minestrone…
Contains undeclared allergen (shrimp).
Product, lots & distribution
Individual Unit Label (both lid and front of cup): Whole Foods Market Kitchens Minestrone Soup, VEGETARIAN NET WT 24 OZ (1 Lb 8OZ) 680g. Case Label: Whole Foods Global Minestrone Soup 702505, KEEP REFRIGERATED, Distributed by Whole Foods Market Austin, TX 78703. Eight (8)/ 24 oz. Cups (Net Wt. 12 LBS)/case. — Distribution: AL, CT, DC, FL, GA, MA, MD, ME, MS, NC, NH, NJ, NY, PA, RI, SC, TN, VA — Lots/codes: Use by: 05/27/26 Lot/Unit Numbers: 1762181 UPC Codes: 099482502065 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMay 18, 2026
AbbVie Inc.: PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-1…
Failed Stability Specifications
Product, lots & distribution
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10. — Distribution: US Nationwide. — Lots/codes: Lot # 402805, 407596, Exp Date: 08/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMay 18, 2026
Eugia US LLC: Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Product, lots & distribution
Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02 — Distribution: US Nationwide. — Lots/codes: Lot, expiry: Lot 3LC26029A, exp Feb-2029; Lot 3LC26031A, exp Mar-2029 — Status: Ongoing (voluntary: firm initiated)
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)
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)
Class IFoodMay 18, 2026
Wilco Peanut Co: Raw Shelled Peanuts (Runner Type) 2,200 lb. Poly Tote Bags and 50kg Poly Bags
Undeclared Tree Nut Allergen
Product, lots & distribution
Raw Shelled Peanuts (Runner Type) 2,200 lb. Poly Tote Bags and 50kg Poly Bags — Distribution: Texas, California, Illinois, and New York. Two vessels in route to Korea. — Lots/codes: Lot Numbers: 50520, 50647, 50519, 50521, 50522, 50777, 50748 — Status: Ongoing (voluntary: firm initiated)
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)
Class IIFoodMay 18, 2026
International Food Products Corporation: Dairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box
Potential for Salmonella
Product, lots & distribution
Dairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box — Distribution: TX, TN, OK — Lots/codes: 5114-50, Lot 26125A6B Item number 502269 Use by 2027-05-05 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 18, 2026
International Food Products Corporation: Dairy House Ingredient Systems Strawberry Dairy Powder 05#5072-50, 50 lb bags
Potential for Salmonella
Product, lots & distribution
Dairy House Ingredient Systems Strawberry Dairy Powder 05#5072-50, 50 lb bags — Distribution: TX, TN, OK — Lots/codes: Lot #26126A6A Use by 2027-05-06 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 15, 2026
PAI Holdings LLC: VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-…
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Product, lots & distribution
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: AE001, expires: 5/31/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 15, 2026
PAI Holdings LLC: VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-…
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Product, lots & distribution
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: AE001, expires: 5/31/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 15, 2026
PAI Holdings LLC: VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL…
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Product, lots & distribution
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: AE006, expires: 5/31/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 15, 2026
PAI Holdings LLC: VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL…
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Product, lots & distribution
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-08. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: AH001, expires: 8/31/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 15, 2026
U.S. Tov, Inc. dba U.S. Trading Company: DRAGONFLY Thai Ginger Powder Net Weight: 4.37 oz (125 g) PRODUCT OF THAILAND Packed for: U.S. Trading Company Hayward, CA 94545-1130 UPC: 721557533567
Potential contamination with lead.
Product, lots & distribution
DRAGONFLY Thai Ginger Powder Net Weight: 4.37 oz (125 g) PRODUCT OF THAILAND Packed for: U.S. Trading Company Hayward, CA 94545-1130 UPC: 721557533567 — Distribution: Domestic: AK, AR, CA, CO, FL, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NE, NM, OR, SC, TX, UT, WA, WI. Foreign: Not applicable. — Lots/codes: 349MCF — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 15, 2026
United States Bakery: Great Value Hawaiian Roll 4pk, Item # F63384. Product is perishable dinner roll ready to eat, sold in a corrugated case of 18 packages (4.5oz net wt.) individually wrapped in la…
Firm observed oily and sticky substance on direct food contact surface packaging of finished product.
Product, lots & distribution
Great Value Hawaiian Roll 4pk, Item # F63384. Product is perishable dinner roll ready to eat, sold in a corrugated case of 18 packages (4.5oz net wt.) individually wrapped in laminated film. This product was never sold in stores and was never available for consumer purchase. All affected product remained at wholesale distribution centers and has been accounted for. — Distribution: Distributed in AL, AR, AZ, CA, FL, GA, IL, IN, LA, ME, MN, MO, MS, NC, NE, NM, NY, OH, OK, PA, SC, TX, UT, VA, WI, and WY. — Lots/codes: W1 116 Julian Codes: 116 119 120 127 134 135 Dates of Production: 4/26/2026 4/29/2026 4/30/2026 5/7/2026 5/14/2026 5/15/2026 — Status: Completed (voluntary: firm initiated)
Class IIFoodMay 15, 2026
GELLERT GLOBAL GROUP: Ruby, Artichoke Hearts Quartered, 5 LB 8 OZ (2500 G) DRAINED WT 3 LBS 6 OZ (1550G), Can, 6 cans per case, Store in dry conditions .
Foreign material (Glass) was found in the product.
Product, lots & distribution
Ruby, Artichoke Hearts Quartered, 5 LB 8 OZ (2500 G) DRAINED WT 3 LBS 6 OZ (1550G), Can, 6 cans per case, Store in dry conditions . — Distribution: The adulterated product was sent to the following states. NY,PA,NJ,CT, — Lots/codes: P: 25/06/2026 BN: 186/2A E: 24/06/2028 Q.A NG — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMay 14, 2026
AVEVA Drug Delivery Systems, Inc.: Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0…
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Product, lots & distribution
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88. — Distribution: Nationwide within the U.S — Lots/codes: Lot #: 56841, Expires: 03/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 14, 2026
Asclemed USA Inc.: Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Product, lots & distribution
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc. — Distribution: US Nationwide. — Lots/codes: Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMay 14, 2026
Fresenius Kabi USA, LLC: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Failed Impurities/Degradations Specifications
Product, lots & distribution
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton) — Distribution: US Nationwide. — Lots/codes: Batch # 6133313, 6133314, Exp Date: 06/2026; Batch # 6133315, Exp Date: 07/2026; Batch # 6133682, Exp Date: 09/2026; Batch # 6134812, 6134813, Exp Date: 04/2027. — Status: Ongoing (voluntary: firm initiated)
Class IFoodMay 14, 2026
IQ PRODUCE, LLC: Enoki Mushroom, Net Weight 150g; Product of Korea; Distributed by IQ Produce UPC: 8809316 814286
Imported Enoki Mushrooms samples collected by Florida Department of Health tested positive for Listeria Monocytogenes.
Product, lots & distribution
Enoki Mushroom, Net Weight 150g; Product of Korea; Distributed by IQ Produce UPC: 8809316 814286 — Distribution: Product was distributed to 3 California customers. — Lots/codes: Lot UI775 — Status: Ongoing (voluntary: firm initiated)
Class IIIFoodMay 14, 2026
United Salt Corp: Salt
Plain salt was labeled as iodized and iodized salt was labeled as plain.
Product, lots & distribution
Salt — Distribution: Texas — Lots/codes: tba — Status: Terminated (voluntary: firm initiated)
Class IFoodMay 13, 2026
Terra Medi LLC: Hellas Meze Golden Smoked Whole Herring
Un-eviscerated fish may be contaminated with clostridium botulinum
Product, lots & distribution
Hellas Meze Golden Smoked Whole Herring — Distribution: MA, NJ, IL, and NY — Lots/codes: production date of 4/12/2025, best before 4/12/2026, L120425F54 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 13, 2026
Nutrisystem Inc: Nutrisystem, Chocolate Cheesecake, 2 oz (57g) packages, Flow Wrapped, 48 units per case, Keep frozen
Undeclared Allergen (Soy)
Product, lots & distribution
Nutrisystem, Chocolate Cheesecake, 2 oz (57g) packages, Flow Wrapped, 48 units per case, Keep frozen — Distribution: The recalled product was distributed to the following states: AL, AR, CO,GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, MS, ND, NE, NM, OH, OK, SC, SD, TN, TX, WI, WV, WY — Lots/codes: Product Code: 40007; Lot Code: CH030426 — Status: Ongoing (voluntary: firm initiated)
Class IFoodMay 13, 2026
CERELES EN GENERAL SAS: Pearl Milling Company Original Pancake & Waffle Mix Complete (Mezcla Para Panqueques y Waffles) Net Wt 5.99 oz (170 g). Packed in 50 - 5.99 oz BOPP Pouch units per master case…
Undeclared allergens: Milk and Soy
Product, lots & distribution
Pearl Milling Company Original Pancake & Waffle Mix Complete (Mezcla Para Panqueques y Waffles) Net Wt 5.99 oz (170 g). Packed in 50 - 5.99 oz BOPP Pouch units per master case. Keep in a cool, dry place. — Distribution: Distributed only in Puerto Rico — Lots/codes: Lot Codes:23A26C6, 24A26A7, 24A26B2, 24A26B5, 24A26A7, 24A26C6, 23A26B5, 24A26A6, 25B26C13, 25B26A14, 25B26B4, 25B26A15, 25B26B1 Expiration Date (s): 01/23/2027 ,01/24/2027 and 02/25/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 12, 2026
ANI Pharmaceuticals, Inc.: Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
Defective Container; packets were found to be either empty or partially full.
Product, lots & distribution
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20 — Distribution: Nationwide in the USA — Lots/codes: Lot M251109, exp Nov 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 12, 2026
IntegraDose Compounding Services LLC: fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, M…
Subpotent Drug
Product, lots & distribution
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1. — Distribution: Nationwide. — Lots/codes: Lot#: 20260310FEN-1, Exp. Date: 09/06/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 12, 2026
Spectra Medical Devices, Llc: Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.
Lack of Assurance of Sterility
Product, lots & distribution
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1. — Distribution: USA Nationwide — Lots/codes: Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IMedicationMay 12, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141,…
Presence of Particulate matter: Particulate matter identified as glass.
Product, lots & distribution
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01. — Distribution: U.S. Nationwide — Lots/codes: Lot HAG2581B, expires: 05/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 12, 2026
Straus Family Creamery: STRAUS FAMILY CREAMERY Vanilla Bean ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed by Straus Family Creamery, Petaluma, CA 94952 UPC: 784830100306
Potential contamination with foreign objects (metal pieces).
Product, lots & distribution
STRAUS FAMILY CREAMERY Vanilla Bean ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed by Straus Family Creamery, Petaluma, CA 94952 UPC: 784830100306 — Distribution: Domestic: CA, CO, AZ, CT, FL, GA, IA, IL, IN, MD, NJ, OR, PA, SC, TX, WA, WI. Foreign: Not Applicable. — Lots/codes: BEST BY: 23 DEC 26; BEST BY: 28 DEC 26 — Status: Ongoing (voluntary: firm initiated)