Glenmark Pharmaceuticals recalls 2.5mg/6.25mg Bisoprolol Fumarate and Hydrochlorothiazide tablets due to traces of ezetimibe found in some batches. Check NDC numbers for affected lots.
“Glenmark Bisoprolol/Hydrochlorothiazide Tablets Recall: Cross Contamination Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31632-glenmark-bisoprolol-hydrochlorothiazide-tablets-recall-cross-contamination-risk. Based on FDA recall #D-0199-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0199-2026%22&limit=1).
The FDA announced on Nov. 21, 2025, that Glenmark Pharmaceuticals Inc., USA is recalling Bisoprolol Fumarate and Hydrochlorothiazide Tablets due to cross-contamination with traces of ezetimibe. The agency classified the Class III recall as voluntary.
How to tell if you have it
Brand: Glenmark Pharmaceuticals
Product: Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg
Lot codes: 17232401 (exp 11/2025), 17240974 (exp 05/2026)
Quantity: 11,136 bottles
Distribution: Nationwide in the USA
The hazard
Testing of reserve samples showed the presence of traces of ezetimibe. The FDA said this cross-contamination constitutes the hazard for the recalled drug.
Context
GovInfoNow's records show Glenmark Pharmaceuticals Inc., USA has had 54 other recalls on record since Nov. 20, 2017. Other recent recalls of similar products include Glenmark Azelaic Acid Gel 15% Recall (July 23, 2026), Glenmark Alyacen Birth Control Tablets Recall (May 27, 2026), and Glenmark Ondansetron Tablets Recall (Dec. 30, 2025).
How to tell if you have this one
Check for NDC numbers: 68462-878-30 (30-count), 68462-878-01 (100-count), or 68462-878-05 (500-count). The affected lots have specific expiration dates and manufacturing dates listed in the recall notice.
Brand
Glenmark Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Medication
Verify the NDC number on your bottle to see if it matches the recalled lots (68462-878-30, 68462-878-01, or 68462-878-05).
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0199-2026 (November 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0199-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.