FDA announces nationwide recall of over 580,000 bottles of blood pressure medication

If you or someone you care about takes medication for high blood pressure, now is the time to double-check the label—more than 580,000 bottles have been recalled, according to the US Food and Drug Administration (FDA).

Here at The GrayVine, we know how important it is to stay informed about your health, especially when it comes to the medications you rely on every day.

Let’s break down what’s happening, what it means for you, and what steps you should take next.

What’s Behind the Recall?

On October 7, Teva Pharmaceuticals USA, a major drug manufacturer based in New Jersey, voluntarily recalled several lots of prazosin hydrochloride capsules.

The FDA classified this as a Class II recall on October 24, which means the risk of serious health consequences is considered remote, but temporary or medically reversible adverse effects are possible.

The culprit? A nitrosamine impurity known as "N-nitroso Prazosin impurity C".

Nitrosamines are a group of chemicals that, in high enough amounts and with long-term exposure, have been linked to an increased risk of cancer.

While the FDA is quick to point out that the probability of serious harm is low, they’re not taking any chances when it comes to your safety.

Also read: FDA issues urgent recall of mislabeled pain medication over life-threatening risks

Which Medications Are Affected?

The recall covers three strengths of prazosin hydrochloride capsules distributed by Teva Pharmaceuticals:

• 1 mg capsules: 181,659 bottles
• 2 mg capsules: 291,512 bottles
• 5 mg capsules: 107,673 bottles

Each bottle may contain anywhere from 100 to 1,000 capsules.

If you’re taking prazosin, it’s crucial to check your prescription bottle for the manufacturer and lot number.

You can find the full list of affected lot numbers on the FDA’s Enforcement Report.

Check your bottle: Lot numbers can help identify whether your medication is part of the recall. Image: FDA.

Also read: Unexpected recall hits beloved chocolate treat sold in stores across 14 states

What Is Prazosin, and Why Is It Prescribed?

Prazosin hydrochloride is a well-established medication used primarily to treat high blood pressure (hypertension).

By relaxing blood vessels, it helps improve blood flow and lower blood pressure, reducing the risk of heart attacks and strokes.

Interestingly, prazosin is also prescribed off-label for people with post-traumatic stress disorder (PTSD), especially to help manage nightmares and sleep disturbances.

If you’re among the millions of Americans who rely on prazosin, you’re not alone.

This medication has been a staple in hypertension management for decades, and for many, it’s a lifeline.

Also read: Massive recall issued for popular pork jerky over dangerous metal contamination

What Should You Do If You Have the Recalled Medication?

Neither Teva nor the FDA has issued specific instructions for patients, but here’s what experts recommend:

• Check Your Medication:
  • Look for the manufacturer (Teva Pharmaceuticals) and the lot number on your prescription bottle.
  • If you’re unsure, your pharmacist can help.
• Contact Your Pharmacist and Doctor:
  • If your medication is part of the recall, call your pharmacy and your healthcare provider right away.
  • They can advise you on next steps and help arrange a replacement prescription if needed.
• Do Not Stop Taking Your Medication Abruptly:
  • High blood pressure can be dangerous if left untreated.
  • Don’t stop taking your medication without first consulting your doctor.
• Dispose of Recalled Medication Safely:
  • If instructed to stop using the recalled capsules, follow your pharmacy’s guidance for safe disposal.
  • Many pharmacies offer medication take-back programs.

Also read: Urgent recall affects 2 popular heart medications sold nationwide

Why Are Nitrosamines a Concern?

Nitrosamines have been in the news before.

Over the past few years, several blood pressure and heartburn medications have been recalled due to similar impurities.

Nitrosamines can form during the manufacturing process or when drugs are stored for long periods.

While occasional exposure is unlikely to cause harm, long-term ingestion—even at low levels—can increase cancer risk.

The FDA has set strict limits on nitrosamine levels in medications and continues to monitor and test drugs to ensure your safety.

This recall is part of their ongoing effort to keep potentially harmful products off the market.

Also read: Traveling with medication? Some over-the-counter drugs could cause trouble abroad

What’s Next for Patients?

If you’re affected by this recall, don’t panic.

The risk is considered low, and your healthcare team can help you find a safe alternative.

There are many other effective blood pressure medications available, and your doctor can work with you to find the best option for your needs.

Staying Safe: Tips for Managing Medication Recalls

• Stay Informed:
  • Sign up for FDA recall alerts or ask your pharmacy to notify you of any recalls affecting your prescriptions.
• Keep a Medication List:
  • Write down the names, dosages, and manufacturers of all your medications. This makes it easier to check for recalls and discuss options with your doctor.
• Ask Questions:
  • Don’t hesitate to ask your pharmacist or doctor about the safety of your medications. They’re there to help you navigate these situations.

A Broader Look: Why Medication Recalls Happen

Recalls can be unsettling, but they’re also a sign that the system is working. The FDA and drug manufacturers routinely test medications for quality and safety.

When a problem is found, they act quickly to protect the public. While it’s inconvenient, it’s also reassuring to know that your health is a top priority.

Read next: Is your cholesterol medication affected by a nationwide recall? Here's what to know

Key Takeaways

• More than 580,000 bottles of prazosin hydrochloride capsules, a blood pressure medication distributed by Teva Pharmaceuticals, have been recalled due to the presence of a potentially cancer-causing chemical impurity.
• The FDA classified the recall as a Class II risk, meaning use of the affected medication may result in temporary or medically reversible health issues, but the chance of serious consequences is considered remote.
• The recall covers 1 mg, 2 mg, and 5 mg capsules, with affected bottles ranging from 100 to 1,000 capsules each.
• People who may have the recalled medication are advised to check the lot number, contact their pharmacist and prescriber, and properly dispose of the affected tablets.

Have you ever been affected by a medication recall? How did you handle it? Do you have tips for keeping track of your prescriptions or questions about blood pressure management We’d love to hear your stories and advice—share your thoughts in the comments below!