Glenmark Zonisamide Capsules Recall: Cgmp Deviations
Glenmark Pharmaceuticals recalls 50mg Zonisamide Capsules due to cGMP deviations. This may affect safety in manufacturing. Check your product details to see if you are affected.
Recall notice
cGMP deviations
Contact the company
What happened, in plain English
Glenmark Pharmaceuticals is recalling 50mg Zonisamide Capsules in 100-count bottles because of manufacturing quality issues. This recall is for prescription-only medication that could pose safety risks if produced without proper quality controls. Read more at govinfonow.com/recall/34812-glenmark-zonisamide-capsules-recall-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/34812-glenmark-zonisamide-capsules-recall-cgmp-deviations · Updated August 18, 2026 · FDA enforcement record: FDA #D-0792-2022
Cite this page
“Glenmark Zonisamide Capsules Recall: Cgmp Deviations.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34812-glenmark-zonisamide-capsules-recall-cgmp-deviations. Based on FDA recall #D-0792-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0792-2022%22&limit=1).
Why it’s dangerous
The recall is due to cGMP (current Good Manufacturing Practice) deviations, which means the medication was produced without following standard quality control procedures. This could potentially lead to safety issues with the medication's effectiveness or purity.
Who’s affected
Prescription patients who have the 50mg Zonisamide Capsules in 100-count bottles with the lot number 29200064 (expiring May 31, 2023) are affected. Patients using this medication for seizures or other conditions are most at risk.
How to tell if you have this one
Check for the 50mg Zonisamide Capsules in 100-count bottles with the lot number 29200064, which expires May 31, 2023. The product is prescription-only and manufactured by Glenmark Pharmaceuticals.
- Brand
Glenmark Pharmaceuticals- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Completed- Distribution
USA nationwide- NDC
68462-128-01, 68462-128-05, 68462-129-01, 68462-129-05, 68462-130-01, 68462-130-05
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0791-2022 | Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01; Lot #: 29200052, Exp 4/30/2023 | 11,136 bottles |
| D-0792-2022 | Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-129-01; Lot #: 29200064, Exp 5/31/2023 | 12,003 bottles |
| D-0793-2022 | Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430; a) Lot #: 29200053, Exp 4/30/2023; b) Lot #: 29200054, Exp 4/30/2023 | a) 7,044 bottles; b) 1,014 bottles |
What to do — step by step
Check Product Details
Look for the lot number 29200064 on the bottle label, which expires May 31, 2023.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 9 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0792-2022 (April 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0792-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.