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Class II · ModerateActive recall

Prazosin Hydrochloride

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

Does this affect you?
Check your lot numberLot: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.
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

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

Who makes it

Made byAppco Pharma LLC, Piscataway, NJ
Brand namePRAZOSIN HYDROCHLORIDE
Generic namePRAZOSIN HYDROCHLORIDE
Active ingredient(s)PRAZOSIN HYDROCHLORIDE
Distributed by / forBiocon Pharma Inc., Iselin, NJ
NDC70377-066-11
Show the full FDA record
Full product labelPrazosin 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.
Recalling firmAppco Pharma LLC
DistributionU.S.A. Nationwide
Quantity88,008 bottles- 100's count
Recall initiated2026-03-27
Report date2026-04-08
Recall completed—
Recall numberD-0419-2026
ClassificationClass II
FDA statusOngoing
Origin on filePiscataway NJ United States

Related

Recent drug recallsCheck 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.