Here's guidance the FDA offers for patients whose prescriptions for this generic alternative could be affected.
Released in 2025, new high blood pressure guidelines from the American Heart Association and the American College of Cardiology spell out that leaving hypertension unchecked doesn’t just increase one’s risk of heart problems or stroke—it could also raise the risk of both dementia and cognitive decline. Says the American Heart Association: “If you have high blood pressure, lowering it now may help protect your brain health in the future.” But a wide-reaching recall effort, announced by the U.S. Food and Drug Administration (FDA) and related to a medication designed to help the heart, warns of a potential concern tied to cancer.
According to a January 30 enforcement report, the recall affects an unspecific number of 100-count bottles of Bisoprolol Fumarate (2.5 milligrams) and Hydrochlorothiazide (6.25 milligrams) tablets. The tablets were distributed across the U.S. and in Puerto Rico.
The FDA’s reasoning for the recall is described as “cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.” An online FDA explainer states that Current Good Manufacturing Practice (abbreviated to CGMP) is a list of regulations that ensure the best quality related to pharmaceuticals. However, “[i]f a company is not complying with CGMP regulations, any drug it makes is considered ‘adulterated’ under the law,” says the agency.
The issue with the impurity specifications relates to FDA guidance involving acceptable intake limits for nitrosamine drug substance-related impurities. Though the FDA describes nitrosamines as being commonly found “in water and foods, including cured and grilled meats, dairy products and vegetables,” their presence in drugs “may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.”
Bisoprolol and hydrochlorothiazide work together to treat high blood pressure, according to the Mayo Clinic. While bisoprolol is a beta-blocker, hydrochlorothiazide works as a water pill, effectively reducing blood pressure by flushing out excess sodium and water from the body.
The provided prescription details are:
- Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg
- 100-count bottle, Rx Only
- Lot #: GBHL24005A
- Expiration date: 09/2026
- Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India
- Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
A company website for Unichem Pharmaceuticals (USA) describes the company as “one of the emerging leaders in the global generic pharmaceutical industry.”
As of January 30, the FDA has labeled the recall as a Class II event, meaning it’s “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” The recall was initiated on January 21, 2026.
The FDA says that any patients taking any prescriptions affected by these possible impurities “should not stop taking their medications.” Instead, the agency recommends talking to a healthcare provider regarding any concerns or to discuss other treatment options.
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