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FDA Drug Recalls

676 recalls · Class II, newest first

Class II · Moderate risk Ongoing Sep 12, 2025

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by…

Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7130-61 D-0010-2026

Class II · Moderate risk Ongoing Sep 12, 2025

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by…

Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7130-06 D-0009-2026

Class II · Moderate risk Ongoing Sep 5, 2025

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario…

Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Apotex Corp. NDC 60505-1003-1 D-0677-2025

Class II · Moderate risk Ongoing Sep 5, 2025

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by…

Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Apotex Corp. NDC 60505-0589-1 D-0676-2025

Class II · Moderate risk Ongoing Sep 5, 2025

Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in…

Reason cGMP deviations: Temperature excursion during transportation.

Sandoz Inc NDC 0781-3528-75 D-0651-2025

Class II · Moderate risk Ongoing Sep 4, 2025

Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by…

Reason Failed Impurity/Degradation Specifications

Zydus Pharmaceuticals (USA) Inc NDC 68382-921-06 D-0657-2025

Class II · Moderate risk Ongoing Sep 4, 2025

Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by…

Reason Failed Impurity/Degradation Specifications

Zydus Pharmaceuticals (USA) Inc NDC 68382-920-06 D-0656-2025

Class II · Moderate risk Ongoing Sep 3, 2025

Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica…

Reason Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of…

Sun Pharmaceutical Industries INC NDC 45567-0655-1 D-0658-2025

Class II · Moderate risk Ongoing Sep 3, 2025

Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi…

Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Zydus Pharmaceuticals (USA) Inc D-0639-2025

Class II · Moderate risk Ongoing Sep 3, 2025

Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi…

Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Zydus Pharmaceuticals (USA) Inc D-0638-2025

Class II · Moderate risk Ongoing Sep 3, 2025

Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi…

Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Zydus Pharmaceuticals (USA) Inc D-0637-2025

Class II · Moderate risk Ongoing Sep 3, 2025

Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi…

Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Zydus Pharmaceuticals (USA) Inc D-0636-2025

Class II · Moderate risk Ongoing Sep 3, 2025

Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi…

Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Zydus Pharmaceuticals (USA) Inc D-0635-2025

Class II · Moderate risk Ongoing Sep 3, 2025

Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi…

Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Zydus Pharmaceuticals (USA) Inc D-0634-2025

Class II · Moderate risk Ongoing Sep 3, 2025

Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi…

Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Zydus Pharmaceuticals (USA) Inc D-0633-2025

Class II · Moderate risk Ongoing Sep 3, 2025

Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi…

Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Zydus Pharmaceuticals (USA) Inc D-0632-2025

Class II · Moderate risk Ongoing Sep 3, 2025

Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi…

Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Zydus Pharmaceuticals (USA) Inc D-0631-2025

Class II · Moderate risk Ongoing Sep 3, 2025

Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi…

Reason CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Zydus Pharmaceuticals (USA) Inc D-0630-2025

Class II · Moderate risk Ongoing Sep 3, 2025

Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each…

Reason Failed Impurities/Degradation Specifications

Glenmark Pharmaceuticals Inc., USA NDC 68462-318-29 D-0021-2026

Class II · Moderate risk Ongoing Sep 2, 2025

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx…

Reason Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 55154-7895-0 D-0625-2025

Class II · Moderate risk Ongoing Sep 2, 2025

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton…

Reason Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-2725-61 D-0624-2025

Class II · Moderate risk Ongoing Sep 2, 2025

Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets…

Reason Failed Content Uniformity Specifications

AvKARE D-0007-2026

Class II · Moderate risk Ongoing Aug 29, 2025

bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th…

Reason Lack of Assurance of Sterility

Fagron Compounding Services D-0646-2025

Class II · Moderate risk Ongoing Aug 28, 2025

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by…

Reason Superpotent drug

Ascend Laboratories, LLC D-0645-2025

Class II · Moderate risk Ongoing Aug 27, 2025

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health…

Reason Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with…

Amerisource Health Services LLC D-0650-2025