Appco Pharma Llc: Prazosin Hydrochloride Capsules, Usp, 1mg, 100-count Bottle
Recall Summary Appco Pharma is recalling Prazosin Hydrochloride Capsules, USP, 1mg (100-count bottles) distributed nationwide because testing found higher-than-acceptable levels of a nitrosamine impurity called N-nitroso-prazosin in the medication. This is a Class II recall affecting all U.S. states and Washington, D.C. The medication was manufactured by Appco Pharma LLC in Piscataway, New Jersey, for Biocon Pharma Inc.
- Recalling firm
- Appco Pharma LLC
- Product
- Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.
- Reason
- cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-03-27
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S.A. Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/1e967ec7-786f-446a-a8fd-167da8ce2a2f