Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited,...
FDA Recall #D-0239-2026 — Class II — November 17, 2025
Product Description
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
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
Preferred Pharmaceuticals, Inc. — Anaheim, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
575 1x10 Foil Blister Packs
Distribution
Natinowide in the USA
Code Information
Lot: J1325J, I1725P, EXP Date: 4/30/2027.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated