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
bisoprolol fumarate and hydrochlorothiazide 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 recalled by FDA. Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
By RecallRadar Editorial Team
Sourced from FDA. Last reviewed March 4, 2026.
This recall involves safety concerns. Take action promptly.
✨ Plain-English Summary
bisoprolol fumarate and hydrochlorothiazide 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 recalled by FDA. Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
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.
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
What You Should Do
- 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:
- 2Stop using the product if your lot/model matches.
- 3Check the FDA notice for specifics.
- 4Follow remedy instructions.
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
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
| # | 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.
Frequently Asked Questions
Is my bisoprolol fumarate and hydrochlorothiazide device affected?
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: bisoprolol fumarate and hydrochlorothiazide recall hub and Food & Drug recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
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Quick Info
- Brand
- bisoprolol fumarate and hydrochlorothiazide
- Category
- drug
- Source Agency
- FDA
- Announced
- November 21, 2025
- Country
- US
- Status
- Active
Source & Verification
Sourced from FDA. Last reviewed March 4, 2026.
- Official source
- FDA
- Announced by source
- November 21, 2025
- Last reviewed by RecallRadar
- March 4, 2026
Official Resources
Use these primary sources for final eligibility and claim instructions.
Open Official Recall NoticeView official notice from FDAStay Protected
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