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Medium risk Drugs & MedicationsClass II

Prazosin Hydrochloride 1mg Capsules Recall

Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: App

Updated March 27, 2026

Prazosin Hydrochloride Capsules, USP 1 mg (100-count bottles) manufactured by Appco Pharma LLC for Biocon Pharma Inc. are being recalled because they contain higher-than-safe levels of a nitrosamine impurity. Long-term exposure to elevated nitrosamines may increase cancer risk.

Is the Appco Pharma LLC recalled? Yes. This product was recalled by FDA on March 27, 2026. Details below.

What is recalled

Prazosin Hydrochloride Capsules, USP, 1 mg, 100-count bottle, NDC 70377-066-11, manufactured by Appco Pharma LLC (Piscataway, NJ) for Biocon Pharma Inc. (Iselin, NJ), Rx only.

Am I affected

You are affected if you have a prescription for Prazosin Hydrochloride Capsules 1 mg in a 100-count bottle with NDC number 70377-066-11. Check the label on your bottle.

What to do right now

Stop taking this medication and contact your pharmacist or doctor immediately. Do not throw the capsules away without instruction. Your doctor can confirm whether your specific bottle is affected and provide an alternative treatment.

The hazard

CGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Brands affected

Appco Pharma LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0419-2026
Classification
Class II
Recalled
March 27, 2026
Read the official notice

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