Reported Dec 10, 2025 · Ongoing
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles,…
Glenmark Pharmaceuticals Inc., USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 619 River Dr · Elmwood Park, NJ · 07407-1317
Is this the product you have?
- 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 byGlenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda
- Manufactured forGlenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430
- Lot codes and dates
Lot #: (a): Lot 17232401exp 11/2025Lot 17240974
- exp 05/2026 (b)
Lot 17232401exp 11/2025Lot 17240974
- exp 05/2026 (c)
Lot 17232401exp 11/2025Lot 17240974exp 05/2026
- Amount recalled
- 11,136 bottles
Where it was sold
- Nationwide
Why it was recalled
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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