FDA-Drug2026-04-08Class IICHEMICAL
Appco Pharma prazosin 2mg capsules recalled for nitrosamine impurity
HEAVY METALSNationwide distribution
Stop using Appco Pharma prazosin capsules
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.
- 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.
Hazard
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Sold states
U.S.A. Nationwide
Affected count
58,896 bottles- 100's count
Manufactured in
262 Old New Brunswick Rd Ste N, Piscataway, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0420-2026More Appco Pharma LLC recalls
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