Class II · ModerateActive recall

Prazosin Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?

Check your lot numberLot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.

Where it was soldU.S.A. Nationwide

Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

Check the lot number and expiry on your medicine against the recall above.
Talk to your pharmacist or doctor before changing anything — don't stop on your own.
Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAppco Pharma LLC, Piscataway, NJ

Brand name	PRAZOSIN HYDROCHLORIDE
Generic name	PRAZOSIN HYDROCHLORIDE
Active ingredient(s)	PRAZOSIN HYDROCHLORIDE
Distributed by / for	Biocon Pharma Inc., Iselin, NJ
NDC	70377-067-11

Show the full FDA record

Full product label	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.
Recalling firm	Appco Pharma LLC
Distribution	U.S.A. Nationwide
Quantity	58,896 bottles- 100's count
Recall initiated	2026-03-27
Report date	2026-04-08
Recall completed	—
Recall number	D-0420-2026
Classification	Class II
FDA status	Ongoing
Origin on file	Piscataway NJ United States

Recent drug recalls Check another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.