Overview
- The voluntary recall covers prazosin hydrochloride capsules distributed nationwide after detection of N‑nitroso Prazosin impurity C above acceptable intake thresholds.
- The FDA classified the event as a Class II recall on Oct. 24, indicating a risk of temporary or medically reversible effects with a remote chance of serious harm.
- Impacted products include 1 mg, 2 mg, and 5 mg strengths in 100‑ to 1,000‑count bottles, with expiration dates spanning October 2025 through February 2027.
- Specific lot numbers have been published by the FDA, and pharmacies and distributors have been directed to remove and return affected lots.
- Patients are urged to check lot codes and consult pharmacists or prescribers for safe replacement rather than stopping therapy, and Teva reports no related complaints to date.