Major Recall: Over 580,000 Bottles of Blood Pressure Medication Recalled Due to Cancer-Causing Chemical

In a significant health alert, the U.S. Food and Drug Administration (FDA) has announced the recall of more than 580,000 bottles of prazosin hydrochloride capsules, a medication commonly prescribed to treat high blood pressure and post-traumatic stress disorder (PTSD)-related sleep disturbances. The recall was initiated by Teva Pharmaceuticals USA, in collaboration with Amerisource Health Services, following the discovery of a potentially cancer-causing impurity in the drug.

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What Is the Contaminant?

The impurity identified is N-nitroso Prazosin impurity C, a type of nitrosamine—a class of chemicals that can form during the manufacturing or storage of drugs and are classified by the FDA as potentially carcinogenic. Laboratory tests revealed that the levels of this impurity in the affected prazosin capsules exceeded the FDA's acceptable daily intake limits.

Details of the Recall

  • Affected Medication: Prazosin Hydrochloride Capsules

  • Strengths: 1 mg, 2 mg, and 5 mg

  • Bottle Sizes: 100, 250, 500, and 1,000 capsules

  • Expiration Dates: October 2025 through February 2027

  • Recall Classification: Class II (indicating that the use of the product may cause temporary or medically reversible adverse health consequences, with a low probability of serious health consequences)

What Should Patients Do?

Patients who have been prescribed prazosin hydrochloride capsules should:

  • Do Not Discontinue Medication Abruptly: Consult with your healthcare provider before stopping the medication, as sudden discontinuation may worsen your condition.

  • Contact Your Pharmacist or Doctor: Discuss alternative treatment options or a replacement medication.

  • Return the Recalled Product: Follow the return instructions provided by your pharmacy or the manufacturer.

Teva Pharmaceuticals has stated that it has not received any reports of adverse events related to the recalled products but is taking precautionary measures to ensure patient safety.