FDA Drug Recalls

778 recalls, newest first

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 III · Low risk Ongoing Aug 28, 2025

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate…

Reason Failed Impurities/Degradation Specifications:

Granules Pharmaceuticals Inc. NDC 70010-034-01 D-0673-2025

Class III · Low risk Ongoing Aug 28, 2025

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate…

Reason Failed Impurities/Degradation Specifications:

Granules Pharmaceuticals Inc. NDC 70010-032-01 D-0672-2025

Class III · Low risk Ongoing Aug 28, 2025

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate…

Reason Failed Impurities/Degradation Specifications:

Granules Pharmaceuticals Inc. NDC 70010-031-01 D-0671-2025

Class III · Low risk Ongoing Aug 28, 2025

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate…

Reason Failed Impurities/Degradation Specifications:

Granules Pharmaceuticals Inc. NDC 70010-030-01 D-0670-2025

Class III · Low risk Ongoing Aug 28, 2025

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate…

Reason Failed Impurities/Degradation Specifications:

Granules Pharmaceuticals Inc. NDC 70010-029-01 D-0669-2025

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 I · High risk Ongoing Aug 28, 2025

Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel…

Reason Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil

Green Lumber Holdings, LLC D-0304-2026

Class I · High risk Ongoing Aug 27, 2025

Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd…

Reason Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets…

Unichem Pharmaceuticals USA Inc. NDC 29300-415-19 D-0655-2025

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

Class II · Moderate risk Ongoing Aug 27, 2025

chlorproMAZINE Hydrochloride Tablets, USP, 100 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-0649-2025

Class II · Moderate risk Ongoing Aug 27, 2025

chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging…

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-0648-2025

Class II · Moderate risk Ongoing Aug 27, 2025

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC…

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-0647-2025

Class II · Moderate risk Ongoing Aug 27, 2025

Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA…

Reason cGMP violations

Atlantic Management Resources Ltd. D-0629-2025

Class II · Moderate risk Ongoing Aug 27, 2025

Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by…

Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.

Zydus Pharmaceuticals (USA) Inc NDC 70710-1377-1 D-0623-2025