FDAFDA · Food and drugs·Recall number D-0533-2025
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
Published July 23, 2025 · Recall initiated: July 9, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- Ascend Laboratories, LLC
- Distributor
- US Nationwide.
- UPC
- 0367877261300
- Lot
- Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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