Unichem Pharmaceuticals recalled Bisoprolol Fumarate and Hydrochlorothiazide tablets on January 21, 2026. The recall affects tablets that do not meet impurity specifications for N-Nitroso Bisoprolol. Consumers should stop using the product and contact their healthcare provider immediately.
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Consumers and healthcare providers should stop using this product immediately. Contact Unichem Pharmaceuticals USA Inc. or your healthcare provider for guidance. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Bisoprolol Fumarate and Hydrochlorothiazide tablets are used to treat high blood pressure and heart failure. Consumers often buy these medications to manage chronic health conditions effectively.
The recall was issued due to the presence of N-Nitroso Bisoprolol, which can cause serious health issues if consumed over time. This impurity indicates a failure to meet safety manufacturing standards.
This recall is not part of a broader industry pattern.
Consumers are urged to stop using this medication immediately, which can cause inconvenience and health concerns for those relying on it for managing their health.
The lot number and expiration date are typically printed on the label of the prescription bottle.
Expect a timeline of 4-6 weeks for refund processing after returning the product.
Keep a copy of your prescription, any communication from Unichem, and photos of the product for your records.
The recall involves Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, in 100-count bottles. These tablets are prescribed only and were manufactured by Unichem Laboratoris Ltd. The affected lot number is GBHL24005A with an expiration date of September 2026.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Subpotent drug
Unichem Pharmaceuticals recalled 60,000 bottles of Doxazosin Tablets on January 21, 2026. The tablets were imprinted with the wrong ID, posing a serious risk to consumers. Healthcare providers and users should stop using the product immediately.
Glenmark Pharmaceuticals recalled over 11,000 bottles of Bisoprolol Fumarate and Hydrochlorothiazide Tablets on November 21, 2025. Testing revealed traces of ezetimibe, posing a health risk. Consumers should stop using the product immediately and contact their healthcare provider.