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Glenmark PharmaceuticadrugHigh PriorityActive

Bisoprolol Fumarate and Hydrochlorot... Contamination Recall

Bisoprolol Fumarate and Hydrochlorothiazide Tab... has been recalled due to cross contamination with other products: testing of reserve samples showed presence of traces of ezetimibe. Consumers who purchased this product should stop using it immediately. Check the official FDA notice for specific lot numbers and return or disposal instructions.

By RecallRadar Editorial Team

Sourced from FDA. Last verified March 4, 2026.

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Key facts

Date announced
November 21, 2025
Source agency
FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Bisoprolol Fumarate and Hydrochlorothiazide Tab... has been recalled due to cross contamination with other products: testing of reserve samples showed presence of traces of ezetimibe. Consumers who purchased this product should stop using it immediately. Check the official FDA notice for specific lot numbers and return or disposal instructions.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand
Glenmark pharmaceutica
Category
drug
Source agency
FDA
Announced
November 21, 2025
Country
US
Status
Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

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

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

  1. 1## 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 Pharmaceutica Agency: FDA | Category: drug Reason: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe What to do:
  2. 2Stop using the product if your lot/model matches.
  3. 3Check the FDA notice for specifics.
  4. 4Follow remedy instructions.
Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
FDA
Announced by source
November 21, 2025
Last reviewed by RecallRadar
March 4, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists 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 is the remedy for this recall?

## 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 Pharmaceutica Agency: FDA | Category: drug Reason: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: Glenmark Pharmaceutica recall hub and Food & Drug recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from FDA

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