Teva, Amerisource recall prazosin bottles over nitrosamine impurity

Teva Pharmaceuticals USA and distributor Amerisource Health Services have voluntarily recalled 580,844 bottles of the blood pressure drug prazosin hydrochloride distributed nationwide after testing found elevated levels of a potentially carcinogenic impurity, the U.S. Food and Drug Administration said. The recall, initiated Oct. 7 and classified by the FDA on Oct. 24 as Class II, affects 1 mg, 2 mg and 5 mg capsule strengths in multiple bottle sizes with expiration dates from October 2025 through February 2027.

Agency testing found levels of N‑nitroso prazosin impurity C, a nitrosamine, that exceeded acceptable intake limits established under the Carcinogenic Potency Categorization Approach. The FDA said the products did not meet manufacturing quality standards. A Class II designation means exposure to the violative product may cause temporary or medically reversible adverse health consequences, and the probability of serious adverse health consequences is considered remote.

The recalled capsules were distributed in several bottle sizes, including 100, 250, 500 and 1,000 count containers. Regulators and the manufacturer have advised pharmacies to remove the affected lots from...