WASHINGTON — Nearly 581,000 bottles of a medication commonly prescribed for high blood pressure have been recalled after tests detected potentially cancer-causing impurities above federally accepted safety limits.
Teva Pharmaceuticals voluntarily issued the recall for prazosin hydrochloride capsules on October 7, according to the U.S. Food and Drug Administration (FDA). The recall was later classified as a Class II health risk on October 24, meaning that use or exposure “may cause temporary or medically reversible adverse health consequences,” though the chance of serious harm is considered remote.
The affected products were distributed nationwide and involve three dosage strengths — 1 mg, 2 mg, and 5 mg — of prazosin hydrochloride. While primarily used to treat high blood pressure and certain prostate conditions, prazosin is also prescribed off-label for managing post-traumatic stress disorder (PTSD) symptoms.
What Triggered the Recall ( Blood Pressure Medication Recalled )
According to the FDA notice, testing revealed that some batches of the medication contained elevated levels of N-nitroso prazosin, an impurity classified as a probable human carcinogen. This substance belongs to a group of nitrosamines, which have been linked to an increased risk of cancer after long-term exposure.
The recall covers:
- 1 mg capsules: 181,659 bottles (NDC 0093-4067-01, 0093-4067-10), Lot Nos. 3010544A and 3010545A, exp. Oct 2025
- 2 mg capsules: 291,512 bottles (NDC 0093-4068-01, 0093-4068-10), multiple lots expiring between Oct 2025 and July 2026
- 5 mg capsules: 107,673 bottles (NDC 0093-4069-01, 0093-4069-52, 0093-4069-05), multiple lots with expirations into 2026
Teva said it has notified distributors and customers directly and is working with the FDA to ensure all affected products are removed from circulation.
Advice for Patients
Health experts urge patients not to stop taking their medication abruptly without medical guidance, as doing so could cause dangerous spikes in blood pressure. Instead, anyone currently using prazosin hydrochloride should contact their pharmacist or healthcare provider to confirm whether their prescription is part of the recall.
Patients can also check the FDA’s official recall database for updated lot numbers and return instructions.
Why This Matters
This blood pressure medication recall is part of a broader trend of pharmaceutical recalls in recent years involving nitrosamine contamination in certain drugs, including medications for diabetes and heartburn. The FDA continues to monitor manufacturing processes closely and is urging pharmaceutical companies to enhance quality control and impurity testing to prevent similar issues in the future.
Contact Information
Patients or healthcare providers with questions can contact Teva Pharmaceuticals for more details about the recall process or replacement options. Further updates will be provided on the FDA’s recall page as the investigation continues.