Recalls / Class II
Class IID-0534-2025
Product
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
- Brand name
- Rizatriptan Benzoate
- Generic name
- Rizatriptan Benzoate
- Active ingredient
- Rizatriptan Benzoate
- Route
- Oral
- NDCs
- 67877-261, 67877-262
- FDA application
- ANDA203269
- Affected lot / code info
- 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.
Why it was recalled
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 135 Us Highway 202 206 Ste 15, N/A, Bedminster, New Jersey 07921-2608
Distribution
- Quantity
- N/A
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-07-09
- FDA classified
- 2025-07-17
- Posted by FDA
- 2025-07-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0534-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.