Washington, October 31, 2025: The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of more than 580,000 bottles of the blood pressure drug Prazosin Hydrochloride after testing revealed elevated levels of a nitrosamine impurity known to increase the risk of cancer with long-term exposure. The medication, manufactured and distributed by Teva Pharmaceuticals USA, is primarily prescribed to treat hypertension and certain heart-related conditions.
The FDA classified the recall as a Class II event, which means use or exposure to the affected product may cause temporary or medically reversible adverse health effects, and the probability of serious health consequences is considered remote. The decision follows an analysis that detected higher-than-permitted levels of a chemical compound identified as N-nitroso Prazosin Impurity C, a type of nitrosamine that can form during drug manufacturing or storage.
According to the FDA notice, the recall covers three strengths of the medication: 1 milligram, 2 milligrams, and 5 milligrams. Approximately 181,659 bottles of the 1-milligram dose, 291,512 bottles of the 2-milligram dose, and 107,673 bottles of the 5-milligram dose are affected. The products were distributed nationwide through retail pharmacies, healthcare providers, and drug distributors. The recall was initiated on October 7, 2025, and publicly posted by the FDA later in the month.
FDA identifies nitrosamine impurity in hypertension medication
Teva Pharmaceuticals confirmed that no adverse health events linked to the impurity have been reported to date. The company said it is working with the FDA to ensure the affected products are removed from distribution channels. Pharmacies and healthcare facilities have been instructed to stop dispensing the impacted lots and to return them to the manufacturer. The FDA urged healthcare professionals and patients to verify lot numbers and discontinue use of recalled batches under medical supervision.
Nitrosamines, including the impurity found in this recall, have been under increased regulatory scrutiny in recent years after being detected in several commonly used medications, including those for blood pressure, diabetes, and heartburn. These compounds are classified as probable human carcinogens based on laboratory testing. While exposure to low levels is not expected to pose an immediate health risk, sustained exposure above acceptable limits may increase the risk of cancer.
Regulatory focus on pharmaceutical quality assurance
Patients currently taking Prazosin Hydrochloride are advised not to stop the medication abruptly without consulting a healthcare professional. Abrupt discontinuation of blood pressure medication can lead to uncontrolled hypertension, which may increase the risk of heart attack, stroke, or other cardiovascular complications. Medical providers are encouraged to discuss alternative treatment options or replacement medications for those affected by the recall. The affected lots carry expiration dates ranging from October 2025 through February 2027.
Teva Pharmaceuticals and the FDA are coordinating follow-up actions, including determining the root cause of the impurity and reviewing manufacturing processes to prevent recurrence. The FDA continues to monitor nitrosamine levels across various drug categories to ensure compliance with safety standards. Consumers and healthcare professionals are encouraged to report any adverse reactions or quality problems related to the recalled product to the FDA’s MedWatch Adverse Event Reporting program.
Patients should consult their pharmacists or physicians to verify whether their prescriptions are part of the affected batches. The recall underscores the FDA’s ongoing oversight of pharmaceutical manufacturing standards and its efforts to protect patients from unsafe drug impurities. While no serious health incidents have been reported, the agency emphasizes vigilance among consumers, pharmacists, and healthcare providers in identifying and addressing contaminated medication supplies. – By Content Syndication Services.