CLASS II ONGOING Drug recall · Reported 23 Jul 2025 · FDA Enforcement Report

Rizatriptan Benzoate Tablets recalled by Ascend Laboratories

Ascend Laboratories is recalling Rizatriptan Benzoate Tablets, USP, distributed nationwide in the US. The recall was initiated on 9 Jul 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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.

NDC67877-261, 67877-262

UPC0367877261300

Quantity recalledN/A

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-0534-2025
FDA event ID: 96770
Recalling firm: Ascend Laboratories, Bedminster, NJ
Brand: Rizatriptan Benzoate
Manufacturer: Ascend Laboratories, LLC
Classification: Class II
Status: Ongoing
Recall initiated: 9 Jul 2025
FDA classified: 17 Jul 2025
Reported: 23 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Nitrosamine Impurity

Timeline

9 Jul 2025	Recall initiated by company
17 Jul 2025	Classified by FDA	+8 days
23 Jul 2025	Published in enforcement report	+6 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: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake 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 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18

Where it was distributed

US Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Which lots are affected?

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.

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 96770

Reported	Class	Recall	Company	Reason	Where
23 Jul 2025	CLASS II	Rizatriptan Benzoate Tablets recalled by Ascend LaboratoriesRizatriptan Benzoate	Ascend Laboratories	Nitrosamine Impurity	Nationwide

More recalls from Ascend Laboratories

All 50

Reported	Class	Recall	Company	Reason	Where
5 Aug 2026Drug	CLASS III	Dabigatran Etexilate Capsules, 150 mg recalled by Ascend LaboratoriesDabigatran Etexilate	Ascend Laboratories	Potency & Assay	Nationwide
5 Aug 2026Drug	CLASS III	Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate	Ascend Laboratories	Potency & Assay	Nationwide
5 Aug 2026Drug	CLASS III	Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate	Ascend Laboratories	Potency & Assay	Nationwide
29 Jul 2026Drug	CLASS III	Dabigatran etexilate Capsules, 110 mg recalled by Ascend LaboratoriesDabigatran Etexilate	Ascend Laboratories	Potency & Assay	Nationwide
29 Jul 2026Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide

Other Rizatriptan Benzoate recalls

All 8

Reported	Class	Recall	Company	Reason	Where
23 Jul 2025Drug	CLASS II	Rizatriptan Benzoate Tablets recalled by Ascend LaboratoriesRizatriptan Benzoate	Ascend Laboratories	Nitrosamine Impurity	Nationwide
12 Jun 2024Drug	CLASS II	Rizatriptan Benzoate Tablets USP, 10 mg, 18-Dose Tablets recalledRizatriptan Benzoate	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
12 Jun 2024Drug	CLASS II	Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg recalledRizatriptan Benzoate	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
12 Jun 2024Drug	CLASS II	Rizatriptan Benzoate Tablets USP, 5mg, 18-Dose Tablets recalledRizatriptan Benzoate	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
12 Jun 2024Drug	CLASS II	Rizatriptan Benzoate Orally Disintegrating Tablets recalledRizatriptan Benzoate	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide