Appco Pharma prazosin capsules recalled for nitrosamine impurity
Appco Pharma LLC is recalling specific lots of prazosin hydrochloride 2mg capsules because they contain higher-than-allowed levels of a nitrosamine impurity called N-nitroso-prazosin. Nitrosamines are chemicals that may increase cancer risk with long-term exposure. No injuries have been reported so far.
From the FDA notice · Read the official notice ↗
What to do
- Check if your prazosin matches one of the recalled lot numbers (2404153UC, 2404154UC, 2502055UC, 2505173UC, or 2505175UC).
- Do not stop taking prazosin without talking to your doctor first.
- Contact your pharmacy or doctor to get a replacement or alternative medication.
- Call Biocon Pharma at 1-833-BIOCON1 or the FDA MedWatch line at 1-888-SAFEMEDS if you have questions.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 58,896 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-0420-2026
In the FDA's words
- Description
- Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11. cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY. Distribution: U.S.A. Nationwide Affected quantity: 58,896 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… (this page)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