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Drug FDA Class II Ongoing cGMP deviation

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

Ascend Laboratories, LLC Published Jul 23, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Ascend Laboratories, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Hazards

N-nitroso-dimethyl-rizatriptan · primary

Affected products (1)

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

RIZATRIPTAN BENZOATE · N/A

NDC: 67877-261, 67877-262, 67877-261-30, 67877-261-01, 67877-261-05, 67877-261-18, 67877-261-25, 67877-262-30, 67877-262-01, 67877-262-05, 67877-262-18, 67877-262-25
Lot codes: 23142117, 24142625
Code info: Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 9, 2025
  2. Published
    Jul 23, 2025
Recall number
D-0533-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.