FDA Drugs recall ·

Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets… recall

Recall number
D-0239-2026
Date
(initiated November 17, 2025)
Company / brand
Preferred Pharmaceuticals, Inc.
1250 N Lakeview Ave Ste O, Anaheim, CA, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
575 1x10 Foil Blister Packs
Hazard tags
Fall
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

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

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Distribution

Natinowide in the USA

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0239-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.