Prazosin Recall: Biocon Pharma 5 mg Rx Bottle
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 |
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.
How to identify the recalled item
| Lot / date codes | 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. . |
|---|---|
| Lot / date codes | 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. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.