Overview
- Teva’s voluntary recall covers specific lots totaling 580,844 bottles of 1 mg, 2 mg, and 5 mg capsules distributed nationwide.
- Testing found N‑nitroso Prazosin impurity C above acceptable intake limits in certain lots.
- The action began Oct. 7 and the FDA classified it as a Class II recall on Oct. 24, indicating risk of temporary or medically reversible effects with serious outcomes considered remote.
- Teva’s internal Health Hazard Assessment rated overall patient harm as medium, according to a California Board of Pharmacy memo.
- Patients are being told to verify lot numbers, consult pharmacists or prescribers, and discard affected pills as prazosin users rely on the drug for hypertension treatment and off‑label PTSD symptom relief.