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Recall Observatory FDA recall evidence

Drug product

Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01

D-0239-2026

November 17, 2025

Class II

Product summary

Firm
Preferred Pharmaceuticals, Inc.
Event
Event 98141
Status
Ongoing
Classification
Class II
Quantity
575 1x10 Foil Blister Packs
Official record key
drug-enforcement:D-0239-2026

Official wording

Reason: 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.

Code information: Lot: J1325J, I1725P, EXP Date: 4/30/2027.

Distribution pattern: Natinowide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.