A New Jersey-based drugmaker is recalling more than 175,000 bottles of a widely used blood pressure medication after regulators found levels of a potential cancer-causing impurity above federal limits, according to a notice from the U.S. Food and Drug Administration.
Recall details
Appco Pharma LLC is pulling back 175,061 bottles of prazosin hydrochloride capsules in 1-milligram, 2-milligram, and 5-milligram strengths, the FDA said in an enforcement report dated March 31. The capsules, used primarily to treat high blood pressure and sometimes prescribed off-label for post-traumatic stress disorder, were distributed nationwide.
The ongoing recall was initiated after testing found nitrosamine drug substance-related impurities—specifically N‑nitroso‑prazosin impurity C—at levels above the agency’s “acceptable intake” threshold. Nitrosamines are chemical byproducts that can form during drug manufacturing or storage and are considered potentially carcinogenic, meaning long-term exposure may increase a person’s risk of developing cancer.
“This type of impurity has been an emerging focus for the agency for several years,” said Dr. Janet Woodcock, a former senior FDA official who has overseen drug quality initiatives, in a recent interview about nitrosamine-related recalls. “We are working with manufacturers to identify and control these contaminants before they reach patients.”
What patients should do
Appco Pharma has not issued a public press release, but the FDA notice says the company is notifying distributors and arranging for the return of affected lots. Pharmacists and wholesalers are being asked to check their inventory against the FDA’s lot and expiration-date list and quarantine any affected product.
Health experts caution patients not to abruptly stop taking their blood pressure medication without medical advice, even when a recall is underway. “Stopping a blood pressure drug suddenly can be more dangerous than the theoretical cancer risk from a nitrosamine impurity,” said Dr. Paul Thompson, a Connecticut cardiologist who has studied drug safety issues. “Patients should call their doctor or pharmacist, confirm if their pills are part of the recall, and switch to an alternative if needed.”
Patients can check the FDA’s online enforcement reports or contact their pharmacy to see whether their prescription is affected. If it is, clinicians say most insurers will cover a therapeutically equivalent substitute.
Broader scrutiny of blood pressure drugs
The Appco action is the latest in a series of blood pressure drug recalls tied to nitrosamine contamination, as regulators around the world tighten oversight of manufacturing processes. In a separate case last year, Teva Pharmaceuticals and Amerisource Health Services voluntarily recalled more than 580,000 bottles of prazosin hydrochloride over elevated nitrosamine levels, prompting similar warnings to patients.
“The good news is that these recalls show the surveillance system is working,” said Dr. Diana Zuckerman, president of the National Center for Health Research, who has followed past nitrosamine outbreaks in heart and blood pressure drugs. “But they also reveal how fragile the drug supply chain can be when quality controls fail at any point in the process.”
Regulators say the immediate health risk from taking the affected prazosin is considered low, because the increased cancer risk is tied to long-term exposure rather than short-term use. Even so, doctors say the episode underscores the importance of reporting side effects and checking FDA alerts, especially for medications used daily over many years.
