United StatesBisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as 30-count (NDC 68462-878-30), 100-count (NDC 68462-878-01) and 500-count (NDC 68462-878-05) bottles (lots 17232401, exp 11/2025; and 17240974, exp 05/2026) manufactured for Glenmark Pharmaceuticals, Inc. are recalled nationwide in the United States. The recall was initiated after testing of reserve samples showed cross-contamination with traces of ezetimibe.
What's 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.
Recalling firm: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ, United States.
How to identify it
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
The hazard
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)