Blood pressure medication recalled over high levels of cancer-causing chemical

A New Jersey-based pharmaceutical company, Teva Pharmaceuticals USA Inc., has issued a voluntary recall of more than half a million bottles of its Prazosin Hydrochloride capsules after tests detected elevated levels of a potentially cancer-causing chemical impurity.

According to a U.S. Food and Drug Administration (FDA) enforcement report, the recall affects 580,844 bottles of the medication, which were distributed nationwide. The company initiated the recall on October 7, 2025, and it was officially classified as a Class II recall on October 24, 2025.

A Class II recall indicates that exposure to the product may cause temporary or medically reversible adverse health consequences, though the probability of serious harm is considered remote.

Reason for the Recall

Testing revealed that the affected capsules contained N-nitroso Prazosin impurity C, a chemical compound linked to cancer risk, at levels above acceptable intake limits. The recall covers Prazosin Hydrochloride Capsules USP in 1 mg, 2 mg, and 5 mg doses.

According to Teva’s internal Health Hazard Assessment, the overall harm risk in the patient population is considered medium, as cited by the California Board of Pharmacy.

Scope of the Recall

In total, 55 lots of Prazosin Hydrochloride capsules were affected by the recall. A complete list of impacted lot numbers has been provided by Teva and is available through FDA’s recall database.

The company emphasized that the recall was voluntary and precautionary, and no patient injuries or related complaints have been reported.

Company Statement

In a statement to NBC Chicago, Teva confirmed the recall and assured patients that no “relevant complaints” related to the recalled lots have been received.

“Prazosin is indicated for the treatment of hypertension, to lower blood pressure, and there are many alternative treatments available to patients,” Teva stated. “Teva prioritizes patient safety and product quality at every stage of a medicine’s lifecycle.”

The company said it has sent recall letters to customers with detailed instructions on how to return affected products.

Patients who currently possess the recalled medication are advised to contact their pharmacy to determine the next steps for returning or disposing of the product. Consumers with additional concerns should consult their prescribing healthcare provider, Teva added.

About Prazosin

Prazosin, commonly marketed under the brand name Minipress, is an alpha-blocker used to treat hypertension by relaxing blood vessels and improving blood flow. It is also prescribed in some cases for post-traumatic stress disorder (PTSD)-related nightmares.

The medication’s recall has prompted healthcare professionals to remind patients that several alternative blood pressure treatments remain available and that discontinuing any prescribed medication should only be done under medical supervision.

Broader Recall Trend

The Prazosin recall follows a recent wave of pharmaceutical recalls across the industry. Last month, Lipitor, a popular cholesterol-lowering drug, was also recalled due to “failed dissolution specifications,” meaning the tablets did not dissolve properly, potentially affecting drug absorption and efficacy.

Source