Rizatriptan 10 mg tablets exceed the acceptable intake limit for nitrosamine
Rizatriptan Benzoate Tablets USP 10 mg are being recalled after detection of N-nitroso-dimethyl-rizatriptan above the FDA recommended acceptable intake limit.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: a nitrosamine impurity measured above the FDA's named acceptable intake limit, with no injury reported in the source.
Plain-English summary
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) unit dose tablets, prescription only, manufactured by Alkem Laboratories Ltd. of India and distributed by Ascend Laboratories LLC of Parsippany, New Jersey, NDC 67877-262-18, are being recalled. The source does not state a quantity.
The stated reason is CGMP deviations: detection of N-nitroso-dimethyl-rizatriptan impurity above the FDA recommended acceptable intake limit. The FDA classified the action as Class II.
Affected lots include 22143653 and 22143675 expiring July 2025 and 22144528 expiring September 2025, together with the further lots listed in the recall notice. Distribution was nationwide in the United States.
Patients holding affected lots should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the distributor.
The recalled product
- Product
- RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Oral tablet
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
UPCs (1)
- 0367877261300
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ascend Laboratories, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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