FDAHealthMarch 27, 2026

Appco Pharma LLC — 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-

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

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: March 27, 2026

U.S.A. Nationwide

What's affected?

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.
Brand: PRAZOSIN HYDROCHLORIDE
Lot code: 2406255UC

Additional details

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. .

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 28,157 bottles- 100's count.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.