Patients taking popular blood pressure medications may need to check their prescriptions after the U.S. Food and Drug Administration (FDA) issued a recall affecting certain lots of Bisoprolol Fumarate and Hydrochlorothiazide tablets. The recall comes amid growing attention to the long-term health risks of untreated hypertension and reflects the FDA’s ongoing oversight to ensure drug safety in the United States.
According to an enforcement report released January 30, 2026, the recall affects 100-count bottles of Bisoprolol Fumarate (2.5 mg) combined with Hydrochlorothiazide (6.25 mg) distributed throughout the U.S. and Puerto Rico. While the exact number of bottles affected has not been disclosed, the FDA classified the event as a Class II recall. This designation indicates that while exposure to the recalled product may cause temporary or medically reversible health consequences, the probability of serious long-term harm is remote.
Understanding the Recall and Its Risks
The FDA cited “cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits” as the reason for the recall. cGMP, or Current Good Manufacturing Practice, is a regulatory standard ensuring that pharmaceutical products are manufactured to the highest quality standards. Noncompliance with these regulations renders any drug “adulterated” under federal law.
Specifically, the issue involves nitrosamine impurities, substances that can occur in certain drugs during manufacturing. According to the FDA, nitrosamines are commonly found in water and foods, including cured meats, grilled foods, dairy, and vegetables. However, when present in medications at levels exceeding regulatory limits and over prolonged periods, nitrosamines may increase the risk of cancer. The FDA’s guidance outlines acceptable intake levels for these impurities to minimize long-term health risks.
The recalled medications—Bisoprolol Fumarate and Hydrochlorothiazide—are widely prescribed to manage high blood pressure. Bisoprolol is a beta-blocker that slows the heart rate and reduces blood pressure, while Hydrochlorothiazide is a thiazide diuretic, or “water pill,” that helps the body eliminate excess sodium and water, lowering blood pressure further. The combination therapy is often favored for patients who require dual mechanisms to maintain healthy blood pressure levels.
Prescription Details for Patients
The specific product affected is:
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Medication: Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP
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Dosage: 2.5 mg / 6.25 mg
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Quantity: 100-count bottle, prescription only
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Lot Number: GBHL24005A
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Expiration Date: September 2026
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Manufacturer: UNICHEM LABORATORIS LTD., Pilerne Industrial Estate, Pilerne, Bardez, Goa 403 511, India
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Distributed by: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816
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NDC: 29300-187-01
Unichem Pharmaceuticals, based in the United States, describes itself as a “leading global generic pharmaceutical company” on its corporate website, emphasizing its reach and influence in supplying generic medications across the country.
Guidance for Patients
The FDA stresses that patients taking the affected medications should not stop taking their prescriptions without consulting a healthcare provider. Abruptly discontinuing blood pressure medication can lead to dangerous spikes in blood pressure, increasing the risk of heart attack, stroke, and other serious cardiovascular events.
Instead, patients are encouraged to contact their healthcare provider to discuss alternative medications or to verify whether their prescription falls within the recalled lot. Pharmacists can assist in confirming lot numbers and arranging replacements if needed.
Brooke Rollins, Secretary of the U.S. Department of Agriculture, has previously highlighted the importance of supporting patients’ health proactively. While her focus was on dietary measures, public health guidance underscores a broader principle: preventive action and early management are crucial for reducing long-term risks, whether related to nutrition or chronic disease management.
Why Blood Pressure Management Matters
The recall coincides with continued emphasis on proactive blood pressure management. The American Heart Association and American College of Cardiology updated their high blood pressure guidelines in 2025, highlighting not only the risk of heart disease and stroke from uncontrolled hypertension but also potential cognitive decline and dementia.
“If you have high blood pressure, lowering it now may help protect your brain health in the future,” the American Heart Association advised. Medications like Bisoprolol and Hydrochlorothiazide remain important tools in achieving these health goals, particularly when paired with lifestyle interventions such as diet, exercise, and regular monitoring.
Monitoring and Next Steps
Healthcare providers are reviewing patients’ prescriptions to determine exposure to the recalled lot. Those taking affected medications should remain vigilant for any unusual symptoms, although the FDA emphasizes that the recall is precautionary and that short-term exposure is unlikely to cause immediate harm.
Patients should also be aware of the broader context of medication recalls. Over the past decade, the FDA has issued multiple recalls related to nitrosamine impurities across various generic medications, including blood pressure medications, diabetes treatments, and heartburn therapies. Each recall reflects the agency’s commitment to maintaining the highest standards for drug manufacturing and protecting public health.
Conclusion
While the FDA recall may cause concern, it also reinforces the importance of vigilance in prescription management. Patients are advised to confirm their medications’ lot numbers, continue treatment unless directed otherwise by a healthcare provider, and seek guidance on alternatives if necessary.
Bisoprolol Fumarate and Hydrochlorothiazide remain essential components of effective blood pressure management. By following professional guidance, patients can navigate the recall safely while continuing to reduce the risk of heart disease, stroke, and cognitive decline.
The FDA and Unichem Pharmaceuticals continue to monitor the situation closely, issuing updates and recommendations as more information becomes available. Patients, caregivers, and healthcare providers are encouraged to remain informed and proactive in addressing the potential risks associated with this recall.
Emily Johnson is a critically acclaimed essayist and novelist known for her thought-provoking works centered on feminism, women’s rights, and modern relationships. Born and raised in Portland, Oregon, Emily grew up with a deep love of books, often spending her afternoons at her local library. She went on to study literature and gender studies at UCLA, where she became deeply involved in activism and began publishing essays in campus journals. Her debut essay collection, Voices Unbound, struck a chord with readers nationwide for its fearless exploration of gender dynamics, identity, and the challenges faced by women in contemporary society. Emily later transitioned into fiction, writing novels that balance compelling storytelling with social commentary. Her protagonists are often strong, multidimensional women navigating love, ambition, and the struggles of everyday life, making her a favorite among readers who crave authentic, relatable narratives. Critics praise her ability to merge personal intimacy with universal themes. Off the page, Emily is an advocate for women in publishing, leading workshops that encourage young female writers to embrace their voices. She lives in Seattle with her partner and two rescue cats, where she continues to write, teach, and inspire a new generation of storytellers.
