More than half a million bottles of a widely prescribed blood pressure medication, prazosin hydrochloride, have been recalled across the United States after tests revealed the presence of a potentially cancer-causing chemical impurity at levels exceeding federal safety limits. The recall, initiated by Teva Pharmaceuticals USA and drug distributor Amerisource Health Services, has sent ripples of concern through pharmacies, clinics, and the millions of Americans who rely on the medication to manage hypertension or, in some cases, symptoms of post-traumatic stress disorder (PTSD).
The U.S. Food and Drug Administration (FDA) announced that the voluntary recall began on October 7, 2025, with Teva Pharmaceuticals USA recalling 580,844 bottles of prazosin hydrochloride in 1 mg, 2 mg, and 5 mg capsule strengths. Amerisource Health Services followed with its own recall on October 26. In total, nearly 590,000 bottles are affected, distributed nationwide in 55 separate lots, according to enforcement reports published by the FDA and cited by Nexstar Media and other outlets.
So, what triggered this sweeping recall? The answer lies in the detection of N-nitroso Prazosin impurity C, a member of the nitrosamine family—a class of chemicals that, in high enough concentrations and over prolonged exposure, may increase the risk of cancer. As the FDA explained, “Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.” The agency further clarified that nitrosamines are commonly found in water and foods, and that “a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.” However, the levels detected in the recalled prazosin capsules exceeded those limits, prompting action.
According to the FDA’s enforcement report, the recall was classified as Class II on October 24, 2025. This designation means that use of the affected product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” The California Board of Pharmacy, citing a Health Hazard Assessment by Teva USA, described the overall harm to patients as “medium.”
Prazosin hydrochloride is not just another pill on the shelf. Doctors routinely prescribe it to relax blood vessels and lower blood pressure, helping to prevent strokes, heart attacks, and kidney failure. The medication is also sometimes used off-label to treat nightmares and sleep disturbances caused by PTSD—a testament to its versatility and importance in both cardiovascular and mental health care. The Mayo Clinic notes, “High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure.”
The affected bottles contain between 100 and 1,000 capsules each, with 181,659 bottles of 1 mg, 291,512 bottles of 2 mg, and 107,673 bottles of 5 mg capsules recalled, as reported by USA TODAY and other sources. Most were distributed by Teva, with a smaller portion from Amerisource. Patients are advised to check their medication’s lot numbers and expiration dates, which can be found in the FDA’s enforcement reports and on the California State Board of Pharmacy website.
For those currently taking prazosin, the recall has raised urgent questions. Should they stop taking their medication immediately? The FDA and Teva have both urged caution. In a statement sent to NBC Chicago, Teva said, “Consumers with questions or concerns should also contact the health care provider who prescribed the medication.” Echoing this, the FDA warned, “Stopping your medicine may be more harmful to your health than continuing to take the recalled medicine” in some cases. The agency’s advice is clear: do not discontinue the medication without first consulting your healthcare provider or pharmacist.
Teva Pharmaceuticals, based in Parsippany, New Jersey, emphasized its commitment to safety: “Teva prioritizes patient safety and product quality at every stage of a medicine’s lifecycle.” The company also stated that, so far, it had not received any “relevant complaints” related to the recalled product. Recall letters have been sent to customers with instructions for returning affected bottles, and both Teva and the FDA have encouraged patients to reach out to their pharmacists and prescribers for guidance on next steps.
While the recall has understandably sparked anxiety among patients, health experts point out that the risk, while real, remains relatively low in the short term. The FDA’s Class II classification means that the probability of serious adverse health consequences is remote, and any health effects are expected to be temporary or medically reversible. Still, the incident highlights the ongoing challenges in pharmaceutical manufacturing, where even small lapses in quality control can have far-reaching consequences for public health.
For those wondering how this could happen, it’s worth noting that nitrosamine impurities can form during the manufacture or storage of certain drugs, especially when chemical reactions or environmental conditions aren’t tightly controlled. The FDA has been increasingly vigilant in monitoring for these impurities since similar recalls affected other medications in recent years, including some widely used blood pressure and cholesterol drugs. In October 2025, Lipitor—a cholesterol-lowering medication—was also recalled for “failed dissolution specifications,” underscoring the complexity of ensuring drug quality across a vast and globalized supply chain.
The recall also shines a light on the prevalence of hypertension in the United States. According to America’s Health Rankings and the Massachusetts General Hospital, 31% of adults in Massachusetts have been told by a health professional that they have high blood pressure. In 2023 alone, the state recorded 719 deaths related to hypertension. Nationwide, millions rely on medications like prazosin to keep their blood pressure in check and reduce the risk of life-threatening complications.
For now, patients affected by the recall are left in a familiar bind: balancing the risks of a potentially contaminated medication against the dangers of uncontrolled hypertension or untreated PTSD symptoms. The FDA, Teva, and healthcare providers are urging calm, careful consultation, and vigilance in checking medication lot numbers. As the dust settles, the episode serves as a potent reminder of the importance of rigorous drug safety standards—and of the need for clear, timely communication when problems arise.
With the recall ongoing and investigations continuing, those who depend on prazosin can only hope that swift action and transparent information will keep them safe, and that the lessons learned will help prevent similar incidents in the future.
