Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd.,
Summary
The FDA issued a Class II for Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, M by Ascend Laboratories, LLC. Reason: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit..
Details
Source
Drug Recall
External ID
D-0534-2025
Action Date
2025-07-23
Status
Ongoing
Category
drug
Product Description
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
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.
Quantity Affected: N/A
Reason for Recall
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-09
Company
Bedminster, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 51 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Ascend Laboratories, LLC has 30 FDA actions in our database, including 30 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ascend Laboratories, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ascend Laboratories, LLC have FDA actions?
Ascend Laboratories, LLC has 30 FDA actions in our database, including 30 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0534-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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