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FDA issues drug recall for cancer-causing impurity in blood pressure pill

Julia Marshall (Morning Digital Producer)
The Food and Drug Administration is recalling a popular blood pressure drug after tests found a potential cancer-causing chemical.
Image credit: AP Foto/Jose Luis Magana, archivo
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Summary

Drug recall

The Food and Drug Administration is recalling more than half a million bottles of prazosin hydrochloride after tests identified carcinogenic impurities in some lots. Teva Pharmaceuticals is conducting the recall voluntarily.

Health risks

Tests by the FDA found a cancer-causing substance that can develop during production or storage of the medication. The FDA states that long-term exposure to this impurity could increase cancer risk, resulting in the posting of a Class II risk.

Patient guidance

The FDA urges patients not to stop taking the recalled medication on their own and recommends consulting a doctor or pharmacist for replacements or alternatives.

Full story

The Food and Drug Administration (FDA) is recalling a popular blood pressure drug after tests found a potential cancer-causing chemical. Teva Pharmaceuticals is voluntarily pulling more than half a million bottles of prazosin hydrochloride off pharmacy shelves.

The medication is commonly used to treat high blood pressure, but doctors also prescribe it to help veterans and PTSD patients with nightmares and anxiety.

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Why the recall?

The FDA says tests found carcinogenic impurities in some lots of the drug. It’s a substance that can form during the manufacture or storage of the drug. It could increase the risk of cancer with long-term exposure, causing the FDA to post a Class II risk.

The recall applies to multiple batches distributed nationwide between April and September, totaling approximately 580,000 bottles.

Patients are urged not to stop taking the drug on their own. Instead, they should contact their doctor or pharmacist for replacements or alternatives.

The FDA says that no injuries or illnesses have been reported so far, but the investigation is ongoing.

Julia Marshall
Julia Marshall (Morning Digital Producer)
Julia Marshall is a morning digital producer at Straight Arrow News. Thanks to her extensive newsroom experience, Julia has a keen eye for news and extensive experience in writing and editing content across all topics and platforms.
Jason Morrell (Morning Managing Editor) and Matt Bishop (Digital Producer) contributed to this report.
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Why this story matters

A major recall of over half a million bottles of blood pressure medication by Teva Pharmaceuticals highlights concerns about the presence of potentially cancer-causing chemicals and emphasizes the importance of patient safety, drug quality and regulatory oversight.

Drug safety

The discovery of carcinogenic nitrosamine impurities in prazosin hydrochloride raises concerns about the long-term health risks to patients and the importance of monitoring drug safety and manufacturing processes.

Regulatory action

The recall and FDA classification as Class II risk illustrate how regulatory agencies respond to potential threats to public health and enforce standards to protect consumers.

Patient guidance

With many patients relying on this medication, clear communication about the recall, potential health risks and the need to consult healthcare providers ensures proper medical guidance and reduces the risk of adverse outcomes.

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Context corner

Nitrosamine impurities have caused recalls of other medications in recent years, leading to increased scrutiny in pharmaceutical manufacturing and storage processes to ensure public health and compliance with regulatory limits.

History lesson

Nitrosamine contamination in pharmaceuticals has led to previous recalls, including drugs like valsartan and ranitidine, prompting regulatory agencies to establish stricter monitoring and manufacturing standards for impurities.

Policy impact

The recall may result in greater regulatory scrutiny on pharmaceutical manufacturing and storage, influencing future industry guidelines and possibly prompting updated FDA policies on permissible impurity limits and recall procedures.

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Sources

  1. AP News

Bias comparison

  • Media outlets on the left emphasize the widespread impact of the recall, using terms like "popular" medication and definitive language such as "cancer-causing chemical" and "tainted," often including crucial patient advice.
  • Media outlets in the center maintain a neutral tone, using phrases like "carcinogen concern" and "may contain," occasionally adding subjective humor or local relevance.
  • Media outlets on the right sometimes introduce a degree of uncertainty with "possible carcinogens" or, conversely, employ strong, unambiguous phrases like "high levels" to underscore severity without detailing the FDA's "Class II" low-risk classification.

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Media landscape

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162 total sources

Key points from the Left

  • More than 580,000 bottles of blood pressure medication are recalled due to a cancer-causing chemical, according to the U.S. Food and Drug Administration .
  • Teva Pharmaceuticals USA issued the voluntary recall on Oct. 7 for certain prazosin hydrochloride capsules classified as a Class II risk by the FDA.
  • The recalled medication may contain nitrosamine impurities, which can lead to severe health risks, as reported by the FDA.

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Key points from the Center

  • Earlier this month, New Jersey-based Teva Pharmaceuticals USA voluntarily recalled certain prazosin hydrochloride capsules, and the FDA classified the recall as Class II last week, covering more than 580,000 bottles nationwide.
  • Regulators say testing found N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach acceptable intake limit, which can form during manufacture or storage and is potentially carcinogenic.
  • The recall lists specific lot details and counts, noting that 181,659 bottles of Prazosin Hydrochloride, 1 mg capsules, 291,512 bottles of 2 mg, and 107,673 bottles of 5 mg are affected, all sold in 100, 500, and 1,000 capsule bottle sizes.
  • The FDA and pharmacists recommend that patients prescribed prazosin check lot numbers, consult their pharmacists and prescribers, and note the FDA warns prolonged nitrosamine exposure may raise cancer risk.
  • High blood pressure affects nearly 119.9 million U.S. Adults, and other manufacturers like Pfizer and Merck have also reported nitrosamine impurities, reflecting a wider industry issue.

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Key points from the Right

No summary available because of a lack of coverage.

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Sources

  1. AP News

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