FDAFDA · Food and drugs·Recall number D-0421-2026
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.
Published April 8, 2026 · Recall initiated: March 27, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- PRAZOSIN HYDROCHLORIDE
- Manufacturer
- Appco Pharma LLC
- Distributor
- U.S.A. Nationwide
- Lot
- 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. .
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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