Appco Pharma LLC recalls Prazosin Hydrochloride Capsules
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Mar 27, 2026
- Reported
- Apr 8, 2026
- Distribution
- U.S.A. Nationwide
- Status
- Ongoing
- Quantity
- 28,157 bottles- 100's count
- Lot / codes
- Lot:2406255UC, Exp.: 2026/MAY; 2406256UC, Exp.: 2026/JUL; 2407313UC Exp.: 2026/JUL; 2408351UC, Exp.: 2026/JUL; 2408352UC , Exp.: 2026/JUL; 2509311UC, Exp.: 2027/SEP. .
- Company location
- Piscataway, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0421-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0421-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.