Overview
- The FDA says affected prazosin hydrochloride lots tested above acceptable intake limits for the nitrosamine identified as N‑nitroso Prazosin Impurity C under its CPCA framework.
- Regulators classified the recall as Class II, indicating a low likelihood of serious harm but requiring removal of compromised product.
- Teva Pharmaceuticals USA and Amerisource Health Services initiated a voluntary nationwide recall covering multiple lots across the United States.
- The action includes 1 mg, 2 mg and 5 mg capsule strengths, with manufacturers and distributors instructed to pull listed lots from the market.
- Prazosin is used to lower blood pressure and is sometimes prescribed for PTSD‑related nightmares, so clinicians advise obtaining replacements rather than interrupting therapy.