[pending] RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
Pending LLM rewrite. Source: FDA_DRUG D-0534-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
The recalled product
- Product
- RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Drugs
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.
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- ModerateRizatriptan Benzoate Tablets Recalled for Out-of-Specification Impurities
FDA (Drugs) · 2021-11-03
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