Reported Jul 23, 2025 · Ongoing
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd.,…
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, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only
- Manufactured byAlkem Laboratories Ltd., INDIA
- Distributed byAscend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
- Lot codes and dates
Lot 231421172314211923142122
- Exp Date
May 2026Lot 24142625
- Exp DateJun. 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.
Want the full recall guide?
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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