The U.S. Food and Drug Administration (FDA) has announced a major blood pressure medication recall after Teva Pharmaceuticals voluntarily withdrew over half a million bottles of prazosin hydrochloride capsules. The recall, classified as a Class II risk, was issued following the detection of a cancer-causing chemical impurity known as N-nitroso Prazosin impurity C.
The FDA confirmed that the voluntary recall began on October 7, 2025, and was officially classified on October 24. The affected medication was distributed nationwide, primarily prescribed for managing high blood pressure and sometimes used off-label to treat post-traumatic stress disorder (PTSD) symptoms such as nightmares and sleep disturbances.
Details of the Blood Pressure Medication Recall
According to the FDA, the recall affects prazosin hydrochloride capsules distributed by Teva Pharmaceuticals USA, based in Parsippany, New Jersey. A total of 580,844 bottles are being recalled, broken down by dosage as follows:
- 1 mg capsules: 181,659 bottles
- 2 mg capsules: 291,512 bottles
- 5 mg capsules: 107,673 bottles
The bottles may contain anywhere from 100 to 1,000 capsules each. The recall was triggered by the discovery of nitrosamine impurities—chemicals known to increase cancer risk through long-term exposure. The specific contaminant, N-nitroso Prazosin impurity C, was identified during quality testing, prompting Teva to act immediately to prevent further distribution.
While the FDA’s Class II recall classification means the product could cause temporary or medically reversible health effects, the likelihood of serious long-term harm is considered low. However, regulators warn that consistent exposure to nitrosamines, even at low levels, could still pose a health risk over time.
What Consumers Should Do Now
Neither Teva nor the FDA has issued direct disposal instructions for consumers, but pharmacy experts recommend checking medication lot numbers and contacting pharmacists or prescribers for guidance. According to GoodRx, affected patients should stop using the recalled medication, consult their healthcare providers about replacement prescriptions, and safely dispose of the contaminated pills following FDA drug disposal guidelines.
Teva has not reported any confirmed injuries or illnesses related to the recall. The company stated it is cooperating fully with regulators and strengthening its manufacturing safeguards to prevent similar incidents in the future.
Impact on Patients and Industry Oversight
This blood pressure medicine recall adds to a growing list of pharmaceutical product recalls in 2025 involving chemical contamination. In recent months, the FDA has issued warnings for several consumer products—including makeup wipes, rice, and pasta—due to contamination or impurity risks.
Healthcare professionals emphasize that patients should not panic but should act quickly to verify their medication. High blood pressure is a chronic condition, and skipping doses without medical advice can be dangerous. Pharmacies nationwide are expected to assist customers in identifying affected bottles and ensuring safe alternatives are provided.
The FDA continues to monitor the recall closely, urging healthcare providers and consumers to report any adverse reactions linked to the recalled prazosin hydrochloride capsules.
FYI (keeping you in the loop)-
Q1: What chemical impurity caused the blood pressure medication recall?
The impurity is known as N-nitroso Prazosin impurity C, a type of nitrosamine associated with potential cancer risks.
Q2: How many bottles of blood pressure medicine were recalled?
Teva Pharmaceuticals recalled more than 580,000 bottles of prazosin hydrochloride capsules in total.
Q3: What should consumers do with recalled medication?
Consumers should check the lot number, stop using the product, and contact their pharmacist or doctor for safe disposal and replacement options.
Q4: What are nitrosamines and why are they dangerous?
Nitrosamines are chemical compounds that can form during drug production and have been linked to an increased risk of cancer through long-term exposure.
Q5: Has anyone been harmed by the recalled prazosin hydrochloride capsules?
As of now, there are no confirmed reports of illness or injury related to this recall.
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