On October 31, 2025, the U.S. Food and Drug Administration (FDA) announced a sweeping recall of prazosin hydrochloride, a widely prescribed medication for high blood pressure and post-traumatic stress disorder (PTSD). The recall, initiated by Teva Pharmaceuticals USA and drug distributor Amerisource Health Services, affects more than 580,000 bottles of the drug distributed nationwide between April and September 2025. The reason? Tests revealed the presence of nitrosamine impurities, specifically N-nitroso prazosin impurity C, a chemical classified as potentially carcinogenic.
The FDA’s decision was swift and decisive. According to the agency’s enforcement report, the affected lots of prazosin hydrochloride—available in 1 mg, 2 mg, and 5 mg capsules—contained levels of the impurity that exceeded the agency’s Carcinogenic Potency Categorization Approach (CPCA) acceptable limit. The CPCA is designed to minimize public exposure to cancer-causing chemicals in medications, and any breach of its threshold is taken seriously.
Prazosin hydrochloride is best known for its ability to relax blood vessels, allowing blood to flow more freely and lowering blood pressure. But its uses stretch beyond hypertension. Doctors frequently prescribe it off-label to manage nightmares and sleep disturbances linked to PTSD, as well as symptoms of benign prostatic hyperplasia and the Raynaud phenomenon, which causes circulation-related discoloration of the fingers and toes. For many patients, it’s a lifeline—so the news of a recall, especially on this scale, hit hard.
Teva Pharmaceuticals, headquartered in New Jersey, voluntarily pulled the medication from pharmacy shelves after the FDA’s findings. The company did not immediately comment on the recall, but the FDA’s public notices and recall orders made the situation clear: the risk, while not immediate, could increase with long-term exposure. The agency classified the recall as Class II, indicating that use of or exposure to the violative product "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
According to Texas Public Radio, the recall covers bottles with specific lot numbers and expiration dates ranging from October 2025 to September 2026. Patients are urged to check their medication bottles carefully. The FDA’s website provides detailed information on the affected lots, but for most consumers, the advice is simple—don’t stop taking your medication on your own. Instead, consult your physician or pharmacist to determine if your prescription is affected and to discuss alternatives or the possibility of a replacement refill.
The culprit in this case, nitrosamine impurities, isn’t unique to prazosin hydrochloride. As reported by The Associated Press and other outlets, nitrosamines can form during the manufacturing or storage of various drugs. They’re naturally found in trace amounts in water and certain foods, but at higher concentrations in medications, they pose a cancer risk. The FDA has grappled with nitrosamine contamination in other pharmaceuticals in recent years, prompting recalls of blood pressure, diabetes, and heartburn medications.
“No one wants to trade high blood pressure for a potentially cancer-causing chemical,” noted a recent report from Prevention, echoing the public’s concern. The FDA, for its part, emphasized that as of the recall date, no injuries or illnesses had been reported. The agency’s investigation is ongoing, and it continues to monitor for adverse events.
For those unfamiliar with the nitrosamine issue, here’s a bit of background: nitrosamines are a class of chemicals that can form when certain drug ingredients are exposed to specific conditions during manufacturing or storage. While low-level exposure is considered relatively safe, higher levels over extended periods may increase cancer risk. The FDA’s CPCA framework helps regulators determine acceptable daily intake limits for such impurities, and any product exceeding those limits is subject to recall.
Amerisource Health Services, the distributor involved in the recall, also issued voluntary notices to pharmacies and healthcare providers nationwide. The affected prazosin hydrochloride capsules can be identified by their lot number and expiration date, details that are now critical for patients and clinicians alike. The recall spans all three strengths of the drug—1 mg, 2 mg, and 5 mg—meaning that virtually anyone prescribed prazosin hydrochloride in the last six months should double-check their supply.
Despite the scale of the recall, the FDA and medical professionals stress the importance of not abruptly discontinuing the medication. High blood pressure and PTSD symptoms can worsen without proper management, and sudden withdrawal from antihypertensive drugs can have serious consequences. “Do not discontinue use of your medication before speaking with your provider,” advised Prevention. Healthcare providers can offer guidance on next steps, including switching to unaffected lots, obtaining a refund, or exploring alternative therapies.
Interestingly, the recall of prazosin hydrochloride is just one of several FDA actions in October 2025. As reported by SFGate and other outlets, the agency also issued recalls for various food products, dietary supplements, and even pet treats—often for reasons ranging from undeclared allergens to bacterial contamination. But the prazosin recall stands out for its sheer scale and the number of patients potentially affected.
For veterans and others who rely on prazosin hydrochloride to manage PTSD-related nightmares, the recall is especially concerning. The drug is considered a mainstay of off-label treatment for sleep disturbances in PTSD, and alternatives may not work as well for every patient. The FDA has not reported any injuries or illnesses linked to the recalled lots, but the agency’s ongoing investigation will determine if further action is needed.
In the meantime, patients are encouraged to remain vigilant. The FDA’s website provides up-to-date information on the recall, including affected lot numbers and instructions for returning or replacing medication. Pharmacies and healthcare providers have also been notified and are prepared to assist patients in identifying and managing affected prescriptions.
As the investigation continues, the FDA’s message is clear: patient safety comes first, and every effort is being made to ensure that medications on the market meet the highest standards for purity and safety. For now, those taking prazosin hydrochloride should keep an eye on their bottles—and an open line of communication with their healthcare providers.
