Bisoprolol Fumarate and Hydrochlorothiazide Tablets recall (Glenmark Pharmaceuticals Inc., USA)
DrugClass IIIOngoing
Summary: Glenmark Pharmaceuticals Inc., USA is recalling Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775,. Reason: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe.
What is being recalled
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
Why
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026
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-0199-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | November 21, 2025 |
| Reported | December 10, 2025 |
| Company | Glenmark Pharmaceuticals Inc., USA |
| Company location | Elmwood Park, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 11,136 bottles |
More recalls from Glenmark Pharmaceuticals Inc., USA · all drug recalls · recalls from November 2025