FDAHealthMarch 27, 2026

Appco Pharma LLC — 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-

⚠️ 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, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.
Brand: PRAZOSIN HYDROCHLORIDE
Lot code: 2404160C

Additional details

Lot:2404160C, Exp.:2026/MAR; 2406253C, Exp.:2026/MAY; 2407311C, Exp.: 2026/JUL; 2407312C, Exp.:2026/JUL; 2408350C, Exp.:2026/JUL; 2505172C, Exp.:2027/MAY; 2506191C, Exp.: 2027/JUN.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 88,008 bottles- 100's count.

View original FDA notice →

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