Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 1...
FDA Recall #D-0246-2026 — Class II — December 30, 2025
Product Description
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
Reason for Recall
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.
Recalling Firm
Glenmark Pharmaceuticals Inc., USA — Elmwood Park, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
96,948 packs
Distribution
Nationwide within the United States
Code Information
Lot #: 19251311, Exp Date April 2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated