Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is RIZATRIPTAN BENZOATE recalled?

The FDA has recorded 6 recalls of RIZATRIPTAN BENZOATE (2024–2025) , recalled under brand like RIZATRIPTAN BENZOATE. 6 still ongoing.

0
Class I (most serious)
6
Class II
0
Class III
6
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of RIZATRIPTAN BENZOATE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. 4
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit 2

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., Class II ongoing
Ascend Laboratories, LLC 2025-07-09 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 24142623, Exp Date: May 2027; Lot 24142624, 24142626, 24143469, Exp Date: Jun. 2027.
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., Class II ongoing
Ascend Laboratories, LLC 2025-07-09 lots: Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark P Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-05-13 lots: Lot#: 19223402; Exp. 7/2024 Lot#: 19224858; Exp. 11/2024 Lot#: 19232492; Exp. 6/2025
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., US Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-05-10 lots: Lot#: 19233788; Exp. 9/2025 Lot#: 19224445; Exp. 9/2024
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Ph Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-05-13 lots: Lot#: 19224857; Exp. 11/2024 Lot#: 19232493; Exp. 6/2025
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-05-10 lots: Lot#: 19224217; Exp. 9/2024 Lot#: 19233789; Exp. 9/2025 Lot#: 19224444; Exp. 9/2024

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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