High Blood Pressure Medication Recalled

High Blood Pressure Medication Recalled in the U.S.: What You Need to Know

In a major public health alert, the U.S. Food and Drug Administration (FDA) has announced a nationwide recall of more than 580,000 bottles of Prazosin Hydrochloride, a widely prescribed medication for high blood pressure (hypertension). The recall was initiated on October 7, 2025, by Teva Pharmaceuticals USA and Amerisource Health Services, following the discovery of elevated levels of a carcinogenic impurity known as N-nitroso Prazosin impurity C.

The FDA classified the recall as Class II, indicating that the drug may cause temporary or medically reversible adverse health effects, with a low probability of serious harm.

What Is Prazosin Hydrochloride?

Prazosin Hydrochloride is an FDA-approved medication used to treat hypertension by relaxing blood vessels and improving blood flow. It is also prescribed off-label for managing post-traumatic stress disorder (PTSD), particularly for alleviating nightmares and sleep disturbances.

The recall affects three dosages:

• 1 mg capsules (Recall number D-0104-2026)
• 2 mg capsules (Recall number D-0105-2026)
• 5 mg capsules (Recall number D-0106-2026)

These products were distributed nationwide and are identifiable by their National Drug Code (NDC) numbers printed on the packaging.

Recalled Lots and NDC Numbers

Here are the specific lots affected:

• 1 mg capsules
  • NDC 0093-4067-01 (100 capsules)
  • NDC 0093-4067-10 (1,000 capsules)
• 2 mg capsules
  • NDC 0093-4068-01 (100 capsules)
• 5 mg capsules
  • NDC 0093-4069-01 (100 capsules)

If your prescription matches any of these, contact your pharmacy or physician immediately for guidance.

What Is a Class II Recall?

A Class II recall is issued when a product may cause temporary or medically reversible health effects, or when the probability of serious adverse health consequences is remote. While not the most severe classification, it still requires prompt attention from affected patients.

What Should Patients Do?

If you are currently taking Prazosin Hydrochloride:

• Do not stop taking the medication abruptly
• Check the NDC and lot number on your prescription bottle
• Contact your healthcare provider for alternatives or further instructions
• Report any adverse reactions to the FDA’s MedWatch program

Patients are strongly advised not to self-discontinue the medication without medical supervision, as doing so may lead to uncontrolled blood pressure or other complications.

Public Health Implications

This recall underscores the importance of stringent pharmaceutical quality control and transparent communication between drug manufacturers, regulators, and the public. With hypertension affecting millions of Americans, ensuring the safety of blood pressure medications is critical to national health.