Reported Jul 23, 2025 · Ongoing
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories…
Ascend Laboratories, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ascend Laboratories, LLC · 135 Us Highway 202 206 Ste 15 · Bedminster, NJ · 07921-2608
Is this the product you have?
- Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only
- Manufactured byAlkem Laboratories Ltd., INDIA
- Distributed byAscend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 July 2025 2 Lot 22144528, Exp Date: September 2025 3 Lot 22144977, Exp Date: November 2025 4 Lot 23140257, Exp Date: December 2025 5 Lot 23140999, Exp Date: Feb. 2026 6 Lot 23141900, 23142118, 23142120, 23142123, Exp Date: May 2026 7 Lot 23144563, 23144565, Exp Date: November 2026 8 Lot 24142623, Exp Date: May 2027 9 Lot 24142624, 24142626, 24143469, Exp Date: Jun. 2027. - Amount recalled
- N/A
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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