FDA-Drug2026-04-08Class IICHEMICAL
Appco Pharma prazosin hydrochloride capsules recalled for nitrosamine impurity
HEAVY METALSNationwide distribution
Stop using recalled prazosin hydrochloride capsules
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.
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
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-0421-2026More Appco Pharma LLC recalls
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief