US Drug Recall Register

FDA Drug Recalls

2,661 recalls, newest first

Class II · Moderate risk Ongoing

Levothyroxine Sodium Tablets

Reason Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.

Accord Healthcare, INC. NDC 16729-450-15 D-0006-2026
Class II · Moderate risk Ongoing

Carbamazepine Extended-Release Tablets

Reason Failed Dissolution Specifications.

Amerisource Health Services LLC NDC 60687-594-21 D-0675-2025
Class II · Moderate risk Ongoing

edunn clarity

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

Private Label Skin Care Inc. D-0668-2025
Class II · Moderate risk Ongoing

Micronized BPO Gel Cleanser 10%

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

Private Label Skin Care Inc. D-0667-2025
Class II · Moderate risk Ongoing

mel rx Skin

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

Private Label Skin Care Inc. D-0666-2025
Class II · Moderate risk Ongoing

Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10%

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

Private Label Skin Care Inc. D-0665-2025
Class II · Moderate risk Ongoing

Skin MD by Dr Monika Kiripolsky

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

Private Label Skin Care Inc. D-0664-2025
Class II · Moderate risk Ongoing

Artisan of Skin

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

Private Label Skin Care Inc. D-0663-2025
Class III · Low risk Ongoing

Espumil

Reason Labeling: Not Elsewhere Classified

Letco Medical LLC D-0138-2026
Class II · Moderate risk Ongoing

Major ChlorproMAZINE Hydrochloride Tablets

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

Major ChlorproMAZINE Hydrochloride Tablets

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

Major ChlorproMAZINE Hydrochloride Tablets

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

Major ChlorproMAZINE Hydrochloride Tablets

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

Major ChlorproMAZINE Hydrochloride Tablets

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

Ketorolac Tromethamine Ophthalmic Solution

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

Cyclophosphamide Injection 500 mg/5 mL

Reason cGMP deviations: Temperature excursion during transportation.

Sandoz Inc NDC 0781-3528-75 D-0651-2025
Class III · Low risk Ongoing

Everolimus tablets 5mg

Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Endo USA, Inc. NDC 49884-125-91 D-0026-2026
Class II · Moderate risk Ongoing

Entecavir Tablets

Reason Failed Impurity/Degradation Specifications

Zydus Pharmaceuticals (USA) Inc NDC 68382-921-06 D-0657-2025
Class II · Moderate risk Ongoing

Entecavir Tablets

Reason Failed Impurity/Degradation Specifications

Zydus Pharmaceuticals (USA) Inc NDC 68382-920-06 D-0656-2025
Class II · Moderate risk Ongoing

Kit for the Preparation of Technetium Tc 99m Mertiatide

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

Sun Pharmaceutical Industries INC NDC 45567-0655-1 D-0658-2025
Class II · Moderate risk Ongoing

Chlorpromazine Hydrochloride Tablets

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

Zydus Pharmaceuticals (USA) Inc D-0639-2025