FDA-Drug2026-04-08Class IICHEMICAL
Appco Pharma prazosin hydrochloride capsules recalled for nitrosamine impurity
HEAVY METALSNationwide distribution
Stop taking recalled prazosin capsules
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.
- 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.
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
88,008 bottles- 100's count
Manufactured in
262 Old New Brunswick Rd Ste N, Piscataway, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0419-2026More Appco Pharma LLC recalls
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