Bisoprolol Fumarate and Hydrochlorothiazide tablets recall (Unichem Pharmaceuticals USA Inc.)
DrugClass IIOngoing
Summary: Unichem Pharmaceuticals USA Inc. is recalling Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, 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. Reason: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
What is being recalled
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, 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
Why
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide and PR. (states named: Puerto Rico)
How to tell if yours is affected
Lot # GBHL24005A, Exp Date: 09/2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0301-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 21, 2026 |
| Reported | February 11, 2026 |
| Company | Unichem Pharmaceuticals USA Inc. |
| Company location | East Brunswick, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | N/A |
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