FDA Recall
TerminatedTerminated: January 5, 2026Historical recordClass II
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.
by RC Outsourcing, LLC
- Reason
- Lack of assurance of sterility.
- Published
- October 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass II
M.O.M Enterprises, LLC.
- Product
- Organic BABY bedtime drops; sleep + immunity blend; Promotes…
- Reason
- Potential yeast contamination.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
OngoingHistorical recordClass II
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.
by Apotex Corp.
- Reason
- Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
- Published
- October 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).
by Apotex Corp.
- Reason
- Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
- Published
- October 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)
by Amerisource Health Services LLC
- Reason
- Failed Dissolution Specifications.
- Published
- October 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
- Published
- October 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
- Published
- October 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 5, 2026Historical recordClass II
Lawrence Wholesale LLC
- Product
- 16/25 Frozen Cooked Tail-On Farm Raised Shrimp; 12oz clear p…
- Reason
- Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
- Published
- October 8, 2025
- Distribution
- Product was distributed to Kroger stores…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 5, 2026Historical recordClass II
Lawrence Wholesale LLC
- Product
- Shrimp Cocktail Bowl; 7oz clear plastic retail packaging. UP…
- Reason
- Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
- Published
- October 8, 2025
- Distribution
- Product was distributed to Kroger stores…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 4, 2025Historical recordClass II
Pepsico Inc
- Product
- Lipton Green Tea Citrus. 16.9 ounce PET Bottle. sold as 12pk…
- Reason
- Undeclared sugar in finished product-primary package does not reflect the product inside bottle.
- Published
- October 8, 2025
- Distribution
- Products distributed in the following st…
View recall →
FDA Recall
OngoingHistorical recordClass III
READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25
by Medline Industries, LP
- Reason
- Subpotent drug
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01
by Granules Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01
by Granules Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01
by Granules Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01
by Granules Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass III
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01
by Granules Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: Market complaints received for gritty texture (grainy)
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass III
TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14
by Consumer Product Partners, LLC
- Reason
- Cross Contamination with Other Products.
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass III
Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14
by Consumer Product Partners, LLC
- Reason
- Cross Contamination with Other Products.
- Published
- October 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
CompletedHistorical recordClass I
Gooder Foods, Inc.
- Product
- GOODLES HERE COMES TRUFFLE CREAMY TRUFFLE FLAVORED CHEDDAR A…
- Reason
- Undeclared allergens (cashews).
- Published
- October 1, 2025
- Distribution
- Foreign Distribution: Canada U.S. Distr…
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
Read the full medical disclaimer.