FDA Identifies Potential Carcinogen in Common Hypertension Drug and Patients Nationwide May Be at Risk

More than 580,000 bottles of a commonly prescribed blood pressure drug have been recalled due to concerns about a potentially cancer-causing impurity. According to an alert from the U.S. Food and Drug Administration (FDA), several lots of prazosin hydrochloride capsules distributed across the country may contain elevated levels of nitrosamine impurities, which are classified as possible human carcinogens.

This recall impacts patients who rely on prazosin for high blood pressure, PTSD-related sleep issues, and other off-label uses. The voluntary recall was issued by Teva Pharmaceuticals USA, a New Jersey-based manufacturer, and Amerisource Health Services, a major pharmaceutical distributor. The affected capsules include 1 mg, 2 mg, and 5 mg dosages.

For patients and their families, this situation raises significant concerns—both about personal health and potential legal options. Exposure to nitrosamines over time may increase cancer risk, especially when taken daily in prescription medications.

What Is Prazosin and Who Takes It?

Prazosin hydrochloride is a medication widely prescribed for hypertension (high blood pressure). By relaxing blood vessels, it helps improve blood flow and reduce strain on the heart. Physicians also prescribe prazosin for off-label use, particularly in cases involving post-traumatic stress disorder (PTSD) where it may reduce nightmares and sleep disturbances.

Prazosin is available in capsule form in three strengths:

  • 1 mg
  • 2 mg
  • 5 mg

Millions of Americans use medications from the same alpha-blocker drug class. When a contamination issue affects this type of medication, large segments of the population may unknowingly be exposed.

Understanding the FDA Recall and Classification

The FDA classified this recall as a Class II recall, meaning that the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote. However, that does not mean there is no risk.

The primary concern is contamination by nitrosamines, a group of chemicals considered probable human carcinogens by the World Health Organization (WHO) and the FDA. Nitrosamines can form during the manufacturing, storage, or degradation of certain drugs—especially in the presence of heat or light.

These chemicals, particularly N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), have been linked to cancers of the:

  • Liver
  • Stomach
  • Bladder
  • Colon
  • Pancreas

The FDA requires manufacturers to test for nitrosamines and keep their levels within strict acceptable daily limits. If those limits are exceeded, as appears to be the case in this recall, action must be taken immediately.

How Widespread Is the Recall?

According to FDA documentation, the recall includes more than 580,000 bottles of prazosin capsules, distributed nationwide. This includes retail pharmacies, hospital pharmacies, mail-order prescription services, and clinics.

All three dosage strengths—1 mg, 2 mg, and 5 mg—are affected. The recall spans multiple lot numbers, which are now posted on the FDA’s official website. Patients are encouraged to check their medication bottles for lot numbers, expiration dates, and manufacturing information.

Due to the size and distribution of the recall, there is a high likelihood that affected bottles may still be in patients’ homes or medicine cabinets.

Health Risks Associated With Nitrosamines

The link between nitrosamines and cancer is well-documented. These compounds can alter DNA and interfere with cell replication, leading to the formation of tumors. Long-term exposure to even low levels may accumulate risk over time.

Potential health effects include:

  • Liver Damage: Nitrosamines are metabolized in the liver and may lead to liver inflammation, fibrosis, or cancer.
  • Gastrointestinal Issues: Chronic exposure may irritate or damage the stomach lining, possibly resulting in ulcers or stomach cancer.
  • Systemic Effects: If nitrosamines circulate in the bloodstream, they can affect multiple organs and increase the overall cancer risk.

For patients already facing high blood pressure or PTSD, the addition of a cancer risk due to contamination is unacceptable.

Legal Rights for Affected Patients

If you or a loved one took prazosin from a recalled batch and later developed serious health conditions, including cancer, you may be eligible to pursue compensation through a product liability lawsuit. Pharmaceutical companies have a duty to ensure that their products are:

  • Manufactured in safe conditions
  • Stored correctly during distribution
  • Properly tested for harmful contaminants

When that duty is breached and patients are harmed, legal remedies may be available. Victims could pursue compensation for:

  • Past and future medical bills
  • Lost wages or reduced earning capacity
  • Pain and suffering
  • Emotional distress
  • Wrongful death (in cases involving fatal cancers)

Who May Be Eligible to File a Lawsuit?

Anyone who took the recalled medication and suffered harm may qualify for legal action. Common qualifying situations include:

  • A cancer diagnosis after extended use of prazosin
  • Documented use of one of the recalled lots
  • Symptoms or liver damage that may be linked to nitrosamine exposure
  • Family members of deceased patients with a history of long-term prazosin use

Legal teams will typically investigate pharmacy records, medical history, lot numbers, and diagnosis timelines to determine the strength of a case.

What to Do if You Took Recalled Prazosin

If you believe you took one of the recalled batches of prazosin:

  1. Stop taking the medication only after speaking with your healthcare provider.
  2. Check the bottle for identifying information, including lot number and manufacturer.
  3. Secure medical records that show how long you were on the medication.
  4. Document any diagnoses, symptoms, or health changes that may have occurred during or after use.
  5. Contact an attorney experienced in pharmaceutical recalls to evaluate your legal options.

No one should suffer due to a drug manufacturer’s failure to ensure product safety. If you were affected, you have the right to explore compensation.

Prazosin Cancer Lawsuit FAQs

What is prazosin used to treat?

Prazosin is primarily prescribed to treat high blood pressure. It is also commonly prescribed for PTSD-related sleep issues, particularly nightmares. It helps by relaxing blood vessels to improve blood flow.

Why was prazosin recalled?

The FDA reported that several lots of prazosin contained nitrosamine impurities, which are considered probable human carcinogens. These chemicals may increase cancer risk, particularly with long-term exposure.

What are nitrosamines?

Nitrosamines are chemical compounds that can form during drug manufacturing or storage. Some are classified as probable or possible human carcinogens and have been linked to cancers of the liver, stomach, and other organs.

How many bottles are affected?

More than 580,000 bottles of prazosin capsules in 1 mg, 2 mg, and 5 mg strengths have been recalled nationwide.

Am I eligible to file a lawsuit if I took the recalled drug?

If you took prazosin from a recalled lot and later developed cancer or another serious health issue, you may be eligible to file a product liability claim. A law firm can evaluate your medical history and determine if your case qualifies.

Do I need proof that I took the recalled product?

Pharmacy records, prescription receipts, and the actual medication bottle can all help confirm whether you received one of the affected lots. Even without the bottle, other documentation may be sufficient.

What kind of compensation can I recover?

You may be entitled to recover costs for medical care, lost wages, emotional suffering, and other losses. If a loved one passed away from a related illness, surviving family members may pursue a wrongful death claim.

Contact Parker Waichman LLP For A Free Case Review

If you or a loved one took prazosin and later suffered from cancer or another serious illness, you may be entitled to compensation. Parker Waichman LLP is a national law firm currently investigating claims related to the prazosin hydrochloride recall and nitrosamine contamination. Our team will help determine if your case qualifies for legal action.

Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free and confidential consultation. Don’t wait—your time to file may be limited. We’re here to help you fight for the compensation you deserve. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.

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