CLASS II ONGOING Drug recall · Reported 12 Jun 2024 · FDA Enforcement Report
Rizatriptan Benzoate Tablets USP, 10 mg, 18-Dose Tablets recalled
Glenmark Pharmaceuticals Inc., USA is recalling Rizatriptan Benzoate Tablets USP, 10 mg, 18-Dose Tablets, distributed nationwide in the US. The recall was initiated on 10 May 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0533-2024
- FDA event ID
- 94606
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Brand
- Rizatriptan Benzoate
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 May 2024
- FDA classified
- 4 Jun 2024
- Reported
- 12 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
Timeline
| 10 May 2024 | Recall initiated by company | |
| 4 Jun 2024 | Classified by FDA | +25 days |
| 12 Jun 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Which lots are affected?
Lot#: 19224217; Exp. 9/2024 Lot#: 19233789; Exp. 9/2025 Lot#: 19224444; Exp. 9/2024
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 94606This product is part of a recall event; the main page for the event is Rizatriptan Benzoate Tablets USP, 5mg, 18-Dose Tablets recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rizatriptan Benzoate Tablets USP, 5mg, 18-Dose Tablets recalledRizatriptan Benzoate | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
More recalls from Glenmark Pharmaceuticals Inc., USA
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
Other Rizatriptan Benzoate recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rizatriptan Benzoate Tablets recalled by Ascend LaboratoriesRizatriptan Benzoate | Ascend Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Rizatriptan Benzoate Tablets recalled by Ascend LaboratoriesRizatriptan Benzoate | Ascend Laboratories | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg recalledRizatriptan Benzoate | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Rizatriptan Benzoate Tablets USP, 5mg, 18-Dose Tablets recalledRizatriptan Benzoate | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Rizatriptan Benzoate Orally Disintegrating Tablets recalledRizatriptan Benzoate | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |