Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.

Class IIModerate

FDAOct 23, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Clomipramine 75mg Capsules (Zydus) - Nitrosamine Risk (2025)

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Class IIModerate

FDAOct 22, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Clomipramine 25mg Capsules (Zydus) - Nitrosamine Risk (2025)

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Class IIModerate

FDAOct 22, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Clomipramine 50mg Capsules (Zydus) - Nitrosamine Risk (2025)

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Class IIModerate

FDAOct 22, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

TYLENOL Extra Strength Acetaminophen (Kenvue) – Defective Container (2025)

Defective Container

Class IIModerate

FDAOct 21, 2025Nationwide• Kenvue Brands LLC

Opdualag Injection (Bristol-Myers Squibb) – Sterility Concern (2025)

Lack of Assurance of Sterility.

Class IIModerate

FDAOct 21, 2025Nationwide• Bristol-Myers Squibb Company

NIACIN Extended-Release Tablets (Golden State) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDAOct 20, 2025Nationwide• Golden State Medical Supply Inc.

Acetaminophen Caffeine Caplets (Aero) – Labeling Mix-up (2025)

Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.

Class IIModerate

FDAOct 17, 2025Nationwide• Aero Healthcare

Prazosin Hydrochloride 2mg Capsules (Amerisource) – Impurity Risk (2025)

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Class IIModerate

FDAOct 16, 2025Nationwide• Amerisource Health Services LLC

Prazosin Hydrochloride 5mg Capsules (Amerisource) – Impurity Risk (2025)

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Class IIModerate

FDAOct 16, 2025Nationwide• Amerisource Health Services LLC

Prazosin Hydrochloride 1mg Capsules (Amerisource) – Impurity Risk (2025)

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Class IIModerate

FDAOct 16, 2025Nationwide• Amerisource Health Services LLC