Teva, Amerisource Recall 580,000+ Prazosin Bottles

Teva Pharmaceuticals USA and distributor Amerisource Health Services voluntarily recalled more than 580,000 bottles of prazosin hydrochloride capsules (1 mg, 2 mg and 5 mg) after tests found N‑nitroso Prazosin impurity C — a nitrosamine — above the FDA's acceptable intake limits. The FDA classified the recall as Class II; regulators note nitrosamines can raise cancer risk in animal studies though human evidence is limited and the short-term risk to individual patients is considered low. Reported totals include about 181,659 bottles of 1 mg, 291,512 bottles of 2 mg and 107,673 bottles of 5 mg (roughly 580,844–581,000 bottles) across multiple lots with expiration dates from October 2025 through February 2027, and the agency posts full lot numbers on its enforcement page. Patients are advised not to stop prazosin abruptly, to check lot numbers against the FDA listing, and to contact their pharmacy or clinician for replacements or disposal instructions. Teva says it has sent letters to customers and has not received complaints; the recall, initiated in mid-October, was announced in a brief FDA enforcement notice without a full agency press release.