Rizatriptan benzoate tablets recalled for manufacturing defect with chemical impurity
Ascend Laboratories is recalling Rizatriptan Benzoate 10 mg tablets nationwide due to elevated levels of a chemical impurity detected during manufacturing. The impurity exceeds FDA acceptable intake limits.
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: FDA Class II recall involving a known genotoxic impurity above FDA acceptable limits with no reported illnesses or injuries to date. This represents a risk-of-harm scenario where potential injury has not yet been reported, qualifying as High severity.
Plain-English summary
Ascend Laboratories, LLC is recalling Rizatriptan Benzoate Tablets, USP, 10 mg distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations that resulted in detection of N-nitroso-dimethyl-rizatriptan impurity above the FDA's recommended acceptable intake limit. This impurity was identified during manufacturing quality controls.
Affected lots include: Lot 22143653, 22143675 (Exp. July 2025); Lot 22144528 (Exp. September 2025); Lot 22144977 (Exp. November 2025); Lot 23140257 (Exp. December 2025); Lot 23140999 (Exp. February 2026); Lot 23141900, 23142118, 23142120, 23142123 (Exp. May 2026); Lot 23144563, 23144565 (Exp. November 2026); Lot 24142623 (Exp. May 2027); and Lot 24142624, 24142626, 24143469 (Exp. June 2027), all NDC 67877-262-18. The product was manufactured by Alkem Laboratories Ltd. in India.
The recalled product
- Product
- RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Prescription
- Hazard
- n-nitroso-impurity
- manufacturing-defect
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.
Related recalls
Same brand · RIZATRIPTAN BENZOATE
- HighRizatriptan Benzoate tablets recalled for N-nitroso impurity above acceptable limits
FDA (Drugs) · 2025-07-23
- HighFDA Recalls Rizatriptan Benzoate Tablets for Manufacturing Impurity
FDA (Drugs) · 2024-06-12
- HighRizatriptan Benzoate Tablets Recalled for Excessive N-Nitroso Impurity
FDA (Drugs) · 2024-06-12
- HighPrescription Rizatriptan Benzoate Tablets Recalled for Chemical Impurity
FDA (Drugs) · 2024-06-12
- HighPrescription migraine drug recalled for manufacturing impurity above FDA limit
FDA (Drugs) · 2024-06-12
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27