Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP

Glenmark Pharmaceuticals Inc., USA has recalled Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 10, 2025 and was initiated on November 21, 2025. It is classified as a Class III recall, which means using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, with approximately 11,136 bottles affected. The company behind the recall is Glenmark Pharmaceuticals Inc., USA, based in Elmwood Park, NJ. The FDA describes the product as: “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 L…”

Why was Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP recalled?

According to the FDA, the stated reason for the recall is: “Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe.”

What should you do?

If you think you may have bought Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, compare it against the product description and identifying codes (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…) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Glenmark Pharmaceuticals Inc., USA or your local health authority.

About this recall

This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.