FDA Drug · D-0246-2026

Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13

Class II · Ongoing

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

Affected lots / codes — check yours against thisLot #: 19251311, Exp Date April 2027

Recalling firm: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 96,948 packs
Distribution: Nationwide within the United States
Recall initiated: December 30, 2025
Classified: December 31, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0246-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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