Glenmark recalls 5mg/6.25mg bisoprolol and hydrochlorothiazide tablets due to failed impurities tests. RX-only 100-count bottles with specific NDC and lot numbers. No remedy stated in recall notice.
“Glenmark Bisoprolol/Hydrochlorothiazide Tablets Recall: Failed Impurities Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33036-glenmark-bisoprolol-hydrochlorothiazide-tablets-recall-failed-impurities-risk. Based on FDA recall #D-0085-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0085-2024%22&limit=1).
The FDA announced on Oct. 20, 2023, that Glenmark Pharmaceuticals Inc., USA voluntarily recalled Bisoprolol Fumarate and Hydrochlorothiazide Tablets due to failed impurity specifications. The recall affects 480 bottles distributed nationwide.
How to tell if you have it
Brand: Glenmark
Product: Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg
Packaging: 100-count Bottle, RX only
NDC: 68462-879-01
Lot#: 17212352
Expiration Date: 11/31/2023
Quantity: 480 bottles
The hazard
The tablets failed impurity and degradation specifications, according to the FDA. The agency classified this as a Class III recall.
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). Other recent recalls of similar products include Unichem Bisoprolol/Hydrochlorothiazide Tablets Recall (Jan. 21, 2026), Sagent Busulfan Injection Recall (May 4, 2026), and Macleods Olanzapine Tablets 5mg Recall (Aug. 27, 2026).
How to tell if you have this one
Check for the 100-count bottle labeled 5mg/6.25mg bisoprolol and hydrochlorothiazide tablets. Look for NDC code 68462-879-01 and lot number 17212352 on the packaging.
Brand
Glenmark
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the NDC code 68462-879-01 and lot number 17212352 on the bottle to confirm it's the recalled item.
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 terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0085-2024 (October 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0085-2024 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.