UPDATE: Nearly 581,000 bottles of a vital high blood pressure medication have been urgently recalled due to dangerously elevated levels of a potential carcinogen. Teva Pharmaceuticals announced the voluntary recall of prazosin hydrochloride capsules on October 7, 2023, following tests that revealed contamination above acceptable safety limits.
The FDA has classified this recall as a Class II risk on October 24, indicating that exposure to these capsules “may cause temporary or medically reversible adverse health consequences.” However, the likelihood of serious health consequences is considered remote. This recall affects three dosage strengths of the medication, which is widely used to manage high blood pressure and prostate conditions. It is also sometimes prescribed off-label for symptoms of post-traumatic stress disorder.
The recalled capsules possess elevated levels of N-nitroso prazosin impurity, according to the FDA report. The specific details of the recalled medications include:
– 1 mg capsules: 181,659 bottles (NDC 0093-4067-01 and 0093-4067-10) with lot numbers 3010544A and 3010545A, expiring in October 2025.
– 2 mg capsules: 291,512 bottles (NDC 0093-4068-01 and 0093-4068-10) across multiple lot numbers, with expiration dates ranging from October 2025 through July 2026.
– 5 mg capsules: 107,673 bottles (NDC 0093-4069-01, 0093-4069-52, and 0093-4069-05) across various lot numbers, with expiration dates extending into 2026.
Patients currently taking these medications are urged to consult their healthcare providers immediately. Sudden discontinuation of blood pressure medication can pose significant health risks. Teva Pharmaceuticals has begun notifying customers by letter, and the recall is ongoing.
Patients with inquiries regarding the recall should reach out to their pharmacist or healthcare provider to verify if their medication is affected and to discuss alternative treatment options.
This urgent recall highlights the ongoing challenges in pharmaceutical safety and underscores the importance of monitoring medication for quality assurance. Stay tuned for further updates as this situation develops.
