Prazosin Recall: Biocon Pharma 5 mg Rx Bottle
Announced 2026-04-08 · FDA
FDA is recalling 28,157 bottles of Prazosin Hydrochloride Capsules, USP, 5 mg, 100-count Rx bottles, distributed nationwide in the U.S. The recall is due to cGMP deviation with detection of N-nitroso-prazosin impurity C (NNP) above acceptable limits. Affected lots include 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.
| Brand | Appco Pharma LLC |
|---|---|
| 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. |
| Reason | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. |
| Severity | moderate |
| Units affected | 88008 |
| Distribution | U.S.A. Nationwide |
| Agency | FDA |
| Recall / campaign no. | 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 YOU SHOULD DO
- Check your bottle's lot number against the recalled lots; if it matches, stop using the product.
- Contact your pharmacy or healthcare provider to discuss replacement or refund options.
- Do not dispose of the product unless advised; follow local disposal instructions or pharmacist guidance.
- For more information, contact Biocon Pharma or Appco Pharma or visit the FDA recall page.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.