Glenmark Pharmaceuticals Inc., USA recalls Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark
Glenmark recalls 10mg Rizatriptan Benzoate orally dissolving tablets due to N-Nitroso Desmethyl Rizatriptan impurity exceeding FDA limits. Affected lots from 19223402 to 19232492.
Lower-risk recall
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Contact the company & request your remedy
What happened, in plain English
Glenmark is recalling 10mg Rizatriptan Benzoate orally dissolving tablets because they contain an impurity that exceeds FDA safety limits. This could pose a health risk if taken regularly. Read more at govinfonow.com/recall/32678-glenmark-rizatriptan-tablets-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32678-glenmark-rizatriptan-tablets-recall-impurity-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0535-2024
Cite this page
“Glenmark Rizatriptan Tablets Recall: Impurity Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32678-glenmark-rizatriptan-tablets-recall-impurity-risk. Based on FDA recall #D-0535-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0535-2024%22&limit=1).
Why it’s dangerous
The tablets contain N-Nitroso Desmethyl Rizatriptan impurities above FDA acceptable levels. This impurity could potentially cause health issues with long-term use, though the risk is not immediate or severe.
Who’s affected
People who purchased the recalled tablets from the listed lots. Those with frequent migraines using this medication are most at risk.
How to tell if you have this one
Check the lot numbers on the packaging: 19223402 (exp. 7/2024), 19224858 (exp. 11/2024), or 19232492 (exp. 6/2025). The product is manufactured by Glenmark Pharmaceuticals in the US.
- Brand
Glenmark- Category
Drug
All 2 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
Ongoing- Distribution
US Nationwide.- NDC
68462-467-74, 68462-467-46, 68462-467-06, 68462-468-74, 68462-468-46, 68462-468-06
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0534-2024 | Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06; Lot#: 19224857; Exp. 11/2024 Lot#: 19232493; Exp. 6/2025 | 2400 cartons |
| D-0535-2024 | Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06; Lot#: 19223402; Exp. 7/2024 Lot#: 19224858; Exp. 11/2024 Lot#: 19232492; Exp. 6/2025 | 13296 cartons |
What to do — step by step
Check Product Lot Number
Look for lot numbers 19223402, 19224858, or 19232492 on the packaging.
Questions people ask
Is this product safe to use?
The FDA has found impurities in the product that exceed acceptable limits, so it is not recommended for use.
How can I tell if I have the recalled product?
Check the lot numbers on the packaging: 19223402 (exp. 7/2024), 19224858 (exp. 11/2024), or 19232492 (exp. 6/2025).
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Glenmark directly for guidance.
Contact Glenmark
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0535-2024 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0535-2024 from Glenmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0535-2024 (May 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0535-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.