November 2025 FDA Recall Drug by Preferred Pharmaceuticals, Inc.
D-0239-2026 - Defective container

This Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc. on November 17, 2025 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed in Natinowide in the USA and the recall is currently ongoing.

Recall Number: D-0239-2026

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.
Initiated
11-17-2025
Reported
12-24-2025
Quantity
575 1x10 Foil Blister Packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98141
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Preferred Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Natinowide in the USA
Product Description About Product Description
Full technical description of the product.
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01

Batch or Lot Expiration Information

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