Teva Pharmaceuticals has issued a recall of over 580,000 bottles of its blood pressure medication, Prazosin, due to contamination with nitrosamines, a chemical linked to cancer. This has led the FDA to issue a Class II alert for the affected lots, following the detection of this impurity in the drug. The recall affects bottles distributed nationwide, with announcements made in late October 2025.
The Affected Medication: Prazosin
Prazosin, a prescription blood pressure pill, is manufactured by Teva Pharmaceuticals. The recall specifically targets Prazosin capsules in various strengths due to the presence of nitrosamines. Over 580,000 bottles of Prazosin are included in the voluntary recall initiated by Teva.
Scope and Scale of the Recall
The recall involves more than 580,000 bottles distributed across the United States. Affected lot numbers and expiration dates for the Prazosin bottles were specified in Teva’s announcement on October 30, 2025. The action was classified as a Class II recall by the FDA, indicating potential temporary or reversible health issues but not immediate danger.
The Contaminant: Cancer-Linked Nitrosamines
Nitrosamines are the cancer-causing chemical impurity detected in the recalled Prazosin bottles. The FDA confirmed the presence of nitrosamines, which are known to pose a risk of cancer with long-term exposure. Contamination with this chemical prompted the immediate pull of over 580,000 bottles from the market.
FDA’s Role and Alert
The FDA issued a Class II alert on October 30, 2025, in response to Teva’s recall of the blood pressure drugs. FDA oversight confirmed the tainting of Prazosin with the cancer-causing chemical in the 580,000 bottles. The agency’s involvement ensures monitoring of the recall process for consumer safety.
Health Risks Associated with the Impurity
Exposure to nitrosamines in medications like Prazosin has been linked to an increased cancer risk. The cancer warning stems from the impurity’s potential to cause harm over time in blood pressure treatments. While the Class II designation suggests lower severity, the FDA highlighted the need for swift action due to the chemical’s carcinogenic properties.
Consumer Actions and Next Steps
Patients using recalled Prazosin should consult their healthcare providers for alternative medications. Teva advised returning affected bottles to pharmacies or retailers as part of the October 31, 2025, recall update. The FDA recommends checking lot numbers against the official recall list to identify impacted products from the 580,000 bottles.
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