Rizatriptan Benzoate Tablets recall
FDA recall D-0534-2025 · initiated Jul 9, 2025
Ascend Laboratories, LLC recalled Rizatriptan Benzoate Tablets in Jul 2025 — an FDA Class II recall (D-0534-2025) because CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake 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: N/A
Details
- Product
- Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18
- Recalling company
- Ascend Laboratories, Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Jul 9, 2025
- FDA report date
- Jul 23, 2025
Frequently asked
- Was Rizatriptan Benzoate Tablets recalled?
- Ascend Laboratories, LLC recalled Rizatriptan Benzoate Tablets in Jul 2025 — an FDA Class II recall (D-0534-2025) because CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Rizatriptan Benzoate Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0534-2025 was: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
- Is a recalled Rizatriptan Benzoate 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 Tablets are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot 22143653, 22143675, Exp Date: July 2025; Lot 22144528, Exp Date: September 2025; Lot 22144977, Exp Date: November 2025; Lot 23140257, Exp Date: December 2025; Lot 23140999, Exp Date: Feb. 2026; Lot 23141900, 23142118, 23142120, 23142123, Exp Date: May 2026; Lot 23144563, 23144565, Exp Date: November 2026; Lot 24142…. 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-0534-2025.