Tejal Somvanshi
Teva Recalls 580,844 Prazosin Bottles Over Cancer-Linked Nitrosamine Impurity
New Jersey pharmaceutical manufacturer initiates voluntary nationwide recall after tests reveal elevated N-nitroso Prazosin impurity C levels exceeding FDA acceptable limits
Teva Pharmaceuticals USA has initiated a voluntary recall of 580,844 bottles of prazosin hydrochloride capsules distributed nationwide. The recall, which began on October 7, 2025, affects three dosage strengths—1 mg, 2 mg, and 5 mg—across 55 different lot numbers. Testing revealed that these medications contain levels of N-nitroso Prazosin impurity C that exceed the FDA’s recommended acceptable intake limits for nitrosamine impurities.
According to FDA enforcement records, the recall was classified as Class II on October 24, 2025. This classification applies when “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” The California State Board of Pharmacy reports that Teva’s Health Hazard Assessment considers the overall harm to the patient population as medium.
Prazosin is an alpha-blocker medication primarily prescribed to treat hypertension. According to the National Center for Biotechnology Information, the drug works by relaxing blood vessels to increase blood flow and reduce blood pressure. The Cleveland Clinic notes that prazosin is sometimes sold under the brand name Minipress. Beyond hypertension treatment, research documented on ClinicalTrials.gov has explored prazosin’s effectiveness for managing PTSD-related nightmares and sleep disturbances.
Understanding Nitrosamine Contamination
The contamination involves N-nitrosamine impurities, which the FDA describes as “a class of potentially cancer-causing chemicals that can form during manufacture or storage of a drug.” According to the FDA’s guidance on nitrosamine impurities, these compounds require strict monitoring based on their carcinogenic potency.
The FDA developed the Carcinogenic Potency Categorization Approach (CPCA) to set acceptable intake limits for different nitrosamine compounds. In this case, testing showed that the prazosin capsules contained N-nitroso Prazosin impurity C at levels exceeding these established safety thresholds. While everyone is exposed to nitrosamines at low levels through water and food, pharmaceutical products must meet stricter purity standards to minimize long-term cancer risk.
Recall Impact by the Numbers
🔍 Check If Your Medication Is Affected
Enter your bottle’s lot number to see if it’s part of the recall. Lot numbers are typically printed on the bottle label.
For the complete list of affected lots, visit the California State Board of Pharmacy recall notice or the FDA enforcement database.
Recalled Products by Dosage
Each bottle contains up to 1,000 capsules
Multiple lot numbers affected
Each bottle contains up to 1,000 capsules
Largest quantity recalled
Each bottle contains up to 1,000 capsules
Highest dosage strength affected
Recall Timeline
Manufacturer Response and Patient Guidance
In a statement, Teva Pharmaceuticals confirmed the voluntary recall of 55 lots of Prazosin Hydrochloride Capsules USP across all three dosage strengths. The company stated: “Prazosin is indicated for the treatment of hypertension, to lower blood pressure, and there are many alternative treatments available to patients. Teva prioritizes patient safety and product quality at every stage of a medicine’s lifecycle.”
The manufacturer emphasized that it has not received any relevant complaints related to the product. Patients currently taking prazosin are advised to contact their pharmacy to determine next steps. Teva has sent recall letters to all customers with specific instructions for returning recalled products. The company also recommends that consumers with questions or concerns contact the healthcare provider who prescribed the medication.
Industry Context: A Growing Concern
This recall is part of a larger pattern of nitrosamine contamination issues affecting the pharmaceutical industry. Similar recalls have affected multiple drug categories in recent years. For instance, duloxetine (used for depression and anxiety) faced recalls due to N-nitroso contamination, and ADHD medications have been recalled over carcinogen risks.
The FDA has intensified scrutiny of pharmaceutical manufacturing processes to detect these impurities earlier. The agency’s guidance documents provide detailed frameworks for testing, acceptable limits, and remediation strategies. These proactive measures aim to protect public health by identifying contamination before widespread patient exposure occurs.
Cardiovascular medications have been particularly scrutinized. Earlier this year, Health Canada recalled heart medications due to labeling errors, while other recalls have involved undeclared ingredients in supplements and unlabeled compounds in nutritional products. Even allergen-related recalls have increased as regulatory oversight expands.
Important Information
What You Should Do Now
Summary
The voluntary recall was initiated on October 7, 2025, and classified by the FDA as Class II on October 24, 2025. The recall covers 580,844 bottles of prazosin hydrochloride capsules across three dosage strengths (1 mg, 2 mg, and 5 mg) distributed by Teva Pharmaceuticals USA and Amerisource Health Services.
Testing revealed levels of N-nitroso Prazosin impurity C exceeding the FDA’s acceptable intake limits for nitrosamine compounds. According to Teva’s Health Hazard Assessment, overall harm to the patient population is considered medium. The company reports no relevant complaints have been received related to the affected products.
Patients currently taking prazosin should check their bottle’s lot number against the recalled lots listed in the official recall notice. Healthcare providers and pharmacists can provide guidance on returning affected medication and obtaining replacements. The FDA and manufacturer emphasize that patients should not stop taking blood pressure medication without medical consultation.
The recall was discussed in relation to the pharmaceutical industry’s ongoing efforts to minimize nitrosamine contamination in drug manufacturing and storage processes.
