Appco Pharma prazosin capsules recalled for nitrosamine impurity
Appco Pharma LLC is recalling specific lots of prazosin hydrochloride 5mg capsules because they contain higher-than-acceptable levels of a nitrosamine impurity (N-nitroso-prazosin). Nitrosamines are chemical contaminants that may increase health risks with long-term exposure. This is a manufacturing quality issue, not a safety defect in the drug itself.
From the FDA notice · Read the official notice ↗
What to do
- Check if your prazosin bottle matches one of the recalled lots (2406255UC, 2406256UC, 2407313UC, 2408351UC, 2408352UC, or 2509311UC).
- Contact your pharmacist or doctor if you have a recalled lot—do not stop taking prazosin without guidance.
- Your pharmacist can provide a replacement from a non-recalled lot or help you switch medications if needed.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 28,157 bottles- 100's count
- Illnesses reported
- None reported
- Manufactured in
- 262 Old New Brunswick Rd Ste N, Piscataway, NJ, United States
- Classification
- Class II
- Recall number
- D-0421-2026
In the FDA's words
- Description
- 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. cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. 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. . Distribution: U.S.A. Nationwide Affected quantity: 28,157 bottles- 100's count
- Hazard
- cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
3 products in this recall
The agency lists each product separately. Check every one you might have.
- Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Pi…D-0419-2026 · 88,008 bottles- 100's count
- Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, P…D-0420-2026 · 58,896 bottles- 100's count
- Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Pi… (this page)D-0421-2026 · 28,157 bottles- 100's count