Appco Pharma prazosin capsules recalled for nitrosamine impurity
Appco Pharma LLC is recalling prazosin hydrochloride 1mg capsules (100-count bottles) because they may contain higher-than-acceptable levels of a nitrosamine impurity. This impurity was detected during manufacturing quality checks. The recall affects specific lot numbers distributed nationwide.
From the FDA notice · Read the official notice ↗
What to do
- Check if your prazosin bottle matches one of the recalled lot numbers (2404160C, 2406253C, 2407311C, 2407312C, 2408350C, 2505172C, or 2506191C).
- Do not stop taking prazosin without talking to your doctor first.
- Contact your pharmacy or doctor if you have a recalled lot.
- Return the affected bottle to your pharmacy.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Prazosin 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.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 88,008 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-0419-2026
In the FDA's words
- Description
- Prazosin 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. cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. 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. Distribution: U.S.A. Nationwide Affected quantity: 88,008 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… (this page)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…D-0421-2026 · 28,157 bottles- 100's count