FDA-Drug2026-04-08Class IICHEMICAL
Appco Pharma prazosin hydrochloride capsules recalled for nitrosamine impurity
What this means
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.
- 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.
The agency's original wording
Hazard
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S.A. Nationwide
Affected count
28,157 bottles- 100's count
Manufactured in
262 Old New Brunswick Rd Ste N, Piscataway, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0421-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.