Rizatriptan Benzoate Orally Disintegrating Tablets recall
FDA recall D-0535-2024 · initiated May 13, 2024
Glenmark Pharmaceuticals Inc., USA recalled Rizatriptan Benzoate Orally Disintegrating Tablets in May 2024 — an FDA Class II recall (D-0535-2024) because CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 13296 cartons
Details
- Product
- 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
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- May 13, 2024
- FDA report date
- Jun 12, 2024
Frequently asked
- Was Rizatriptan Benzoate Orally Disintegrating Tablets recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Rizatriptan Benzoate Orally Disintegrating Tablets in May 2024 — an FDA Class II recall (D-0535-2024) because CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Rizatriptan Benzoate Orally Disintegrating Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0535-2024 was: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
- Is a recalled Rizatriptan Benzoate Orally Disintegrating Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Rizatriptan Benzoate Orally Disintegrating Tablets are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot#: 19223402; Exp. 7/2024 Lot#: 19224858; Exp. 11/2024 Lot#: 19232492; Exp. 6/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0535-2024.