Drug recall D-0420-2026
Product
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.
Reason for recall
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Lots and codes
Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.
Recall details
- Recalling firm
- Appco Pharma LLC, Piscataway, NJ
- Quantity
- 58,896 bottles- 100's count
- Distribution
- U.S.A. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 27, 2026
Related products
- Prazosin Hydrochloride – drug information
- NDC 70377-067 Prazosin hydrochloride · Prazosin Hydrochloride 2 mg/1 · Biocon Pharma Inc.
- NDC 70377-068 Prazosin hydrochloride · Prazosin Hydrochloride 5 mg/1 · Biocon Pharma Inc.
- NDC 70377-066 Prazosin hydrochloride · Prazosin Hydrochloride 1 mg/1 · Biocon Pharma Inc.