Appco Pharma Llc: Prazosin Hydrochloride Capsules, Usp, 5mg, 100-count Bottle
Prazosin Hydrochloride Capsules Recall Summary Appco Pharma is recalling Prazosin Hydrochloride Capsules 5mg (100-count bottles) distributed nationwide because the medication contains higher-than-acceptable levels of a nitrosamine impurity called N-nitroso-prazosin impurity C. Prazosin is a blood pressure medication sold under prescription. The recall affects bottles distributed across all U.S. states and territories.
- Recalling firm
- Appco Pharma LLC
- Product
- Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.
- 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/460ed5ea-0ef7-42b4-9b2f-1e6e56f0a5db