drug recall

Blood Pressure Medication Recall: What Australians Need to Know About Cancer-Causing Chemicals in Prazosin

If you or a family member are on blood pressure medication, it’s time to check your medicine cabinet. A major global recall has pulled 580,000 bottles of prazosin hydrochloride — a widely used drug for hypertension — off shelves in the United States due to contamination with a cancer-causing chemical. While the recall is currently centred in the U.S., Australian health authorities and pharmacists are on high alert, and the implications could ripple across our shores.

This isn’t just another routine pharmaceutical hiccup. The U.S. Food and Drug Administration (FDA) has flagged the recall as a Class II recall, meaning the contaminated product could cause temporary or medically reversible adverse health consequences — or, in worst-case scenarios, a serious but not life-threatening risk, including potential long-term cancer risk.

Let’s break down what’s happening, why it matters, and what you should do if you’re taking this medication.

What’s Been Recalled? The Verified Facts

In late 2025, Teva Pharmaceuticals, one of the world’s largest generic drug manufacturers, issued a voluntary recall of prazosin hydrochloride capsules after the FDA found traces of N-nitroso-prazosin, a nitrosamine impurity linked to cancer risk.

According to AP News, the FDA confirmed that the contamination stems from a manufacturing process involving nitrosating agents — chemicals used in synthesis that, under certain conditions, can react with the drug compound to form potentially carcinogenic byproducts.

“The recall involves more than 580,000 bottles of prazosin hydrochloride capsules distributed by Teva Pharmaceuticals,” reported CBS News, citing the FDA.

The recalled batches include multiple strengths (1mg, 2mg, and 5mg) and were distributed nationwide in the U.S. between March 2024 and October 2025. While the recall is U.S.-focused, Australian health experts are watching closely.

Recent Updates: Timeline of Key Developments

Here’s a breakdown of the critical events, based on verified news reports and FDA communications:

• Late October 2025: FDA detects nitrosamine impurities in prazosin hydrochloride during routine quality testing.
• Early November 2025: Teva Pharmaceuticals initiates a voluntary nationwide recall of 580,000+ bottles across multiple lot numbers.
• Mid-November 2025: FDA upgrades the recall to Class II — indicating a potential health hazard but not an immediate life-threatening emergency.
• Late November 2025: U.S. retailers and pharmacies pull affected products; FDA publishes full list of recalled lot numbers on its Drug Recalls database.
• December 2025: Global health agencies, including Australia’s Therapeutic Goods Administration (TGA), issue alerts to local manufacturers and importers to review supply chains for potential contamination.

While no Australian-specific recalls have been issued yet, the TGA has confirmed it is reviewing the safety of imported prazosin products and has urged local manufacturers to test for nitrosamine impurities.

“We are closely monitoring the situation,” a TGA spokesperson told The Australian. “We are working with international regulators and local suppliers to ensure the safety of medicines available to Australian patients.”

Why Is This a Big Deal? The Nitrosamine Problem

You might be wondering: What’s the big deal about a “cancer-causing chemical” in my pills?

The issue lies with nitrosamines — a class of chemical compounds known to be carcinogenic in animals and probable human carcinogens based on long-term exposure studies. While low levels of nitrosamines are found in everyday items like processed meats, beer, and cosmetics, the concern with pharmaceuticals is prolonged exposure.

Prazosin is often taken daily for years, especially by older adults managing chronic hypertension. Even trace levels of nitrosamine impurities, when consumed over time, can increase cancer risk — particularly for cancers of the gastrointestinal tract, liver, and kidneys.

This isn’t the first time nitrosamines have caused a stir in the pharma world. Since 2018, the FDA and European Medicines Agency (EMA) have been investigating nitrosamine contamination in sartan drugs (like valsartan and losartan) and diabetes medication (metformin). The prazosin recall is the latest in a growing trend of nitrosamine-related recalls.

“Nitrosamine impurities are a systemic issue in generic drug manufacturing,” says Dr. Sarah Lim, a pharmaceutical safety expert at the University of Sydney. “The problem often lies in synthetic pathways, solvent use, or recycled equipment — things that can be overlooked in cost-driven production.”

This has led regulators worldwide to tighten manufacturing standards, requiring nitrosamine risk assessments for all new and existing drug applications.

Context: A Global Pattern of Drug Recalls

The prazosin recall fits into a larger pattern of global pharmaceutical recalls driven by chemical contamination:

• 2018–2020: Over 100 recalls of sartan blood pressure drugs (e.g., valsartan) due to NDMA (N-nitrosodimethylamine) contamination.
• 2020–2022: Recalls of ranitidine (Zantac) due to NDMA — leading to its eventual withdrawal from the U.S. market.
• 2023–2025: Multiple statin (cholesterol) drugs, including atorvastatin (generic Lipitor), recalled over nitrosamine risks — affecting over 140,000 bottles in the U.S. alone.

These recalls have exposed vulnerabilities in the global supply chain, where active pharmaceutical ingredients (APIs) are often manufactured in low-cost countries with less stringent oversight. Teva, for example, sources many of its APIs from India and China, where regulatory scrutiny varies.

In Australia, over 80% of generic drugs rely on imported APIs, making the country highly dependent on overseas quality control. This raises concerns about whether similar contamination could be present in Australian-sold prazosin or other generics.

“The TGA does rigorous testing, but it’s impossible to test every batch,” says pharmacist James Tran from Sydney’s HealthHub Pharmacy. “When a global recall hits, we have to act fast — even if the product isn’t officially recalled here.”

Immediate Effects: What’s Happening Now?

For Patients

If you’re taking prazosin hydrochloride, do not stop taking it without consulting your doctor. Abruptly stopping blood pressure medication can lead to hypertensive crisis, stroke, or heart attack.

Instead: - Check your medicine bottle for the brand, strength, and batch number. - If your medication is Teva-branded or generic prazosin from a U.S. distributor, contact your pharmacist. - Australian patients should ask their pharmacist or doctor if their specific batch is under investigation. - The TGA website (tga.gov.au) has a recall search tool — you can enter your product details to check for alerts.

For Pharmacists and GPs

• Pharmacists are flagging prazosin prescriptions for review.
• GPs are reassessing patients on long-term prazosin and considering alternative antihypertensives like amlodipine, lisinopril, or candesartan — which are not currently linked to nitrosamine contamination.
• Some clinics are offering free medication reviews for at-risk patients.

For the Pharmaceutical Industry

• Teva is under scrutiny for quality control practices.
• Other generic manufacturers are rushing to test their prazosin batches for nitrosamines.
• The FDA and EMA are likely to increase unannounced inspections of API suppliers.

For Regulators

• The TGA is working with the FDA to share data.
• Australia may introduce stricter import testing for high-risk drug categories, including hypertension and cholesterol medications.
• There’s growing support for real-time recall alerts via Medicare or My Health Record.

Future Outlook: What’s Next?