FDA-Drug2026-04-08Class IICHEMICAL
Appco Pharma prazosin 2mg capsules recalled for nitrosamine impurity
What this means
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.
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
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-0420-2026Want us to check the next one for you?
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