What Was Recalled and Why
The recall affects Bisoprolol Fumarate (2.5 mg) and Hydrochlorothiazide (6.25 mg) tablets — a combination medication commonly prescribed to treat high blood pressure. The affected product comes in 100-count bottles and was distributed throughout the United States and Puerto Rico.
The FDA initiated the recall on January 21, 2026, and officially listed it in its enforcement report on January 30, 2026.
The reason for the recall: the manufacturer failed to meet acceptable limits for a chemical impurity called N-Nitroso Bisoprolol — a type of nitrosamine compound. The FDA has been increasingly vigilant about nitrosamine contamination in generic drugs in recent years, and for good reason.
While nitrosamines occur naturally in some foods — including cured meats, dairy, and certain vegetables — their presence in medications at elevated levels “may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time,” according to the FDA.
