More than 580,000 bottles of a commonly prescribed blood pressure medication have been recalled across the United States after tests revealed elevated levels of a potentially cancer-causing chemical. The drug in question, Prazosin Hydrochloride, is used to treat hypertension and is often sold under the brand name Minipress. The recall, initiated by Teva Pharmaceuticals USA Inc., has raised new concerns about quality control in the pharmaceutical supply chain.
Why Prazosin Was Recalled: Contaminant Above Safety Limits
According to the U.S. Food and Drug Administration (FDA), the voluntary recall was triggered after testing revealed that some lots of the capsules contained levels of N-nitroso Prazosin impurity C that were above the acceptable daily intake limits. This compound is part of a broader class of chemicals called nitrosamines, which have been linked to cancer in humans. The contaminant can form during the drug manufacturing process under certain chemical conditions, particularly if raw materials or solvents are not carefully controlled.
As reported by NBC Chicago, the recall covers 580,844 bottles of Prazosin in 1 mg, 2 mg, and 5 mg dosages. It was initiated on October 7, 2025, and officially classified as a Class II recall by the FDA on October 24. A Class II recall means that while the product may cause temporary or reversible health problems, the risk of serious harm is relatively low.
What the Recall Means for Patients and Healthcare Providers
Patients currently taking Prazosin are advised not to stop the medication abruptly without first consulting a healthcare professional. Abrupt withdrawal could lead to dangerous spikes in blood pressure, which carries its own serious risks. The California Board of Pharmacy, citing Teva’s own Health Hazard Assessment, stated that the potential harm to patients is considered “medium.” This implies that while the contamination poses a risk, it is not considered life-threatening for most patients in the short term.
Healthcare providers, including doctors and pharmacists, are being asked to check inventory and patient prescriptions for the affected lot numbers. A full list of impacted batches has been made available by Teva. For now, the recommendation is to switch patients to uncontaminated alternatives where necessary and to stay alert for any reported side effects potentially related to the contaminated lots.
How Nitrosamine Contaminants Are Changing Drug Regulation
The presence of nitrosamines in medications is not a new issue, but the scale and frequency with which they are now being detected has led to tightened regulatory controls. The FDA, along with other international regulatory bodies such as the European Medicines Agency (EMA), now requires pharmaceutical companies to conduct risk assessments and enhanced chemical testing of their products.
Nitrosamines can form at multiple points in the production chain—from raw materials and solvents to packaging. These complexities mean companies must re-evaluate every step of their manufacturing processes and ensure preventive measures are in place. Since 2018, the FDA has issued multiple guidance documents instructing manufacturers to identify and limit nitrosamine impurities in both active ingredients and finished products. The Prazosin case is just the latest example showing why those guidelines matter.
What Comes Next: Vigilance and Transparency
Patients can check whether their medication is part of the recall by looking up lot numbers listed on FDA recall databases or contacting their pharmacies. For those affected, physicians can provide alternative blood pressure treatments that are not part of the recall. Pharmacists also play a crucial role in identifying impacted batches and informing patients of next steps.
At a broader level, this recall is yet another signal that stronger oversight and clearer communication are urgently needed in the pharmaceutical industry. As medications continue to be manufactured in complex global supply chains, transparency and accountability must remain central to drug safety efforts. Only through better coordination between regulators, companies, and healthcare providers can patient trust be protected.
