Overview
- FDA enforcement reports identify specific 1 mg, 2 mg, and 5 mg lots—totaling 580,844 bottles—distributed nationwide and now subject to return.
- Laboratory testing detected N-nitroso Prazosin impurity C in amounts exceeding the agency’s CPCA acceptable intake limit for the affected lots.
- The action began as a voluntary recall on Oct. 7 and was classified by the FDA as Class II on Oct. 24.
- Teva reported no relevant complaints to date and advises patients to check lot numbers and contact their pharmacist or prescriber rather than stopping the medication abruptly.
- Pharmacies and distributors are removing and returning the lots, prazosin is used for hypertension and often off-label for PTSD-related nightmares, and Teva’s hazard assessment rated overall patient harm as medium.