FDA Drug Recalls

14,450 recalls · Class II, newest first

Class II · Moderate risk Ongoing Sep 12, 2025

ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210

Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with…

Private Label Skin Care Inc. D-0663-2025

Class II · Moderate risk Ongoing Sep 12, 2025

Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed…

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 0904-7133-61 D-0013-2026

Class II · Moderate risk Ongoing Sep 12, 2025

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

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 0904-7132-61 D-0012-2026

Class II · Moderate risk Ongoing Sep 12, 2025

Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed…

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 0904-7131-61 D-0011-2026

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