FDA Recall
Ongoing
Historical 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
Ongoing
Historical 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
Terminated
Historical 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
Terminated
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
Completed
Historical 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 →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Gooder Foods, Inc.
- Product
- GOODLES VEGAN IS BELIEVIN' PLANT-BASED WHITE CHEDDAR WITH SP…
- Reason
- Undeclared allergens (milk).
- Published
- October 1, 2025
- Distribution
- Foreign Distribution: Canada U.S. Distr…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
- Published
- September 24, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Entecavir Tablets, USP, 1 mg, 30 Tablets, 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
- Published
- September 24, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, 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
- Published
- September 24, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.
by Unichem Pharmaceuticals USA Inc.
- Reason
- Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
- Published
- September 24, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.
by Northwind Pharmaceuticals LLC
- Reason
- Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Published
- September 24, 2025
- Distribution
- Nationwide
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.
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