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The Food and Drug Administration (FDA) classified the drug recall as Class II, indicating that temporary or medically reversible health consequences are possible. The drug is used by people with high blood pressure — a condition affecting nearly 100 million Americans — and is also often used off-label for PTSD-related nightmares and sleep issues. The capsules are being recalled due to the presence of a nitrosamine impurity linked to cancer risk. Food and drug recalls are a fact of life. The good news is that most of the time, companies that produce a defective or contaminated product do the right thing and issue a recall as soon as they become aware of a problem. This is known as a voluntary recall. When a company refuses to alert the public that they have released a defective or contaminated product, they can be forced to issue a recall by the Food and Drug Administration. Fortunately, these mandatory recalls happen only rarely. Even with the many production safeguards around sanitation and manufacturing, practically every day, a food or a consumer product faces a recall. And there are always risks. Just this year, there was a recall on a popular Costco Kirkland brand prosecco because the unopened bottles were shattering, which could potentially cause serious injury. There have been dozens of food recalls due to contamination with salmonella or listeria. Earlier this month, a drug used by millions of people to control cholesterol faced a widespread recall. Now another drug, this one used by people with hypertension, is facing a recall because of potential contamination with a cancer-causing chemical. “I think it’s amazing that we don’t have a million people dead every year from a product failure,” pharmacist and pharmacotherapy professor Joey Mattingly said in an August 2025 interview with MedShadow. Teva Pharmaceuticals’ drug recalled over contamination The latest drug to face a recall is prazosine, a drug used by millions of Americans who have high blood pressure. Here’s what you need to know. The Federal Drug Administration said more than 580,000 bottles of the blood pressure medication are being recalled over concerns that the drug may have been contaminated with a cancer-causing chemical. Teva Pharmaceuticals USA and drug distributor Amerisource Health Services issued the voluntary nationwide recall of various strengths of the capsules, according to the FDA enforcement report. The capsule drug, formally known as prazosin hydrochloride, comes in 1 mg, 2 mg, and 5 mg doses. It helps relax blood vessels to facilitate blood flow and is sometimes prescribed for sleep disturbances, including nightmares caused by post-traumatic stress disorder. Prazosin hydrochloride recall details: Manufacturer: Teva Pharmaceuticals USA (Parsippany, NJ) Drug name: Prazosin Hydrochloride Capsules Lot #s: 1016996, 1018336, 1021220; Expiration Date 11/30/2025 Lot #s: 1022421, 1025017; Expiration Date: 08/31/2026 Total bottles recalled: ~580,000+ 1 mg capsules: 181,659 bottles 2 mg capsules: 291,512 bottles 5 mg capsules: 107,673 bottles Bottle size: 100 to 1,000 capsules each Recall type: Voluntary, announced Oct. 7; FDA classification changed to Class II on Oct. 24. Risk factor: Possible contamination with a nitrosamine impurity (“N-nitroso Prazosin impurity C”), known for cancer-causing potential. Uses: Approved for high blood pressure treatment and also used off-label for sleep issues in people with PTSD. What to do: Patients should check lot numbers, contact their pharmacist and prescriber, and follow FDA “MedWatch” reporting if needed (no specific disposal instructions yet). Why this hypertension drug recall is important Hypertension affects nearly half of U.S. adults — and many of them are on medication. Some 48% of U.S. adults had hypertension, according to the most recent data from the Centers for Disease Control, and about half of them reported taking prescribed blood-pressure medication. With such a large population potentially relying on these drugs daily, a recall of this magnitude resonates widely. The recall isn’t flagged as immediately life-threatening, but the presence of a nitrosamine impurity raises long-term risk concerns — especially for chronic use. In other words, the risk is less about immediate toxicity and more about what could happen over time. What people who take prazosin hydrochloride for high blood pressure should do While Teva and the FDA haven’t issued detailed disposal or replacement instructions, experts recommend: Check your prescription bottle’s lot number against the FDA recall list. Speak with your prescribing physician before halting or switching medication. Properly dispose of recalled medication if yours is affected — and check FDA’s MedWatch to report any issues. Monitor for any unexpected symptoms and keep a log of batch numbers in case follow-up becomes necessary. What this drug recall means for consumers This recall highlights vulnerabilities in the pharmaceutical supply chain and quality control— particularly among generics and widely used therapies. For manufacturers, the costs can be substantial: logistics, replacement product, regulatory reporting, and reputational damage all add up. For consumers and healthcare providers, it reinforces the need to stay aware — even familiar medications carry risk. When a brand-name drug gets replaced by generics, the supply-chain complexity often increases, raising oversight challenges. If you or someone you care for takes prazosin HCl, take a moment to verify the lot number now.
