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Ondansetron ODT Tablets recall
Recalled by Preferred Pharmaceuticals, Inc. of Anaheim, CA · FDA report 12/24/2025
Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.
- Class
- Class II
- Moderate
- Status
- Ongoing
- Recall started
- 11/17/2025
- Distribution
- See below
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.
Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Recalled product
- Product
- Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
- Lot and code info
- Lot: J1325J, I1725P, EXP Date: 4/30/2027.
- Quantity
- 575 1x10 Foil Blister Packs
- Recall number
- D-0239-2026
- Event ID
- 98141
- Initiated by
- Voluntary: Firm initiated
Where it was distributed
Natinowide in the USA
Recall timeline
- 11/17/2025Firm started the recall
- 12/17/2025FDA classified it as Class II
- 12/24/2025Published in the FDA enforcement report
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- Class IIDrugOngoing05/07/2025Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark...Preferred Pharmaceuticals, Inc. · cGMP Deviations
- Class IIDrugOngoing09/04/2024Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's...Preferred Pharmaceuticals, Inc. · Failed Impurities/Degradation Specifications - at 18-month...
- Class IIDrugOngoing05/29/2024Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC...Preferred Pharmaceuticals, Inc. · CGMP Deviations: Presence of N-nitroso-duloxetine impurity above...
- Class IIDrugOngoing07/12/2023Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count...Preferred Pharmaceuticals, Inc. · Failed Stability Specifications
Frequently asked questions
- Why was Ondansetron ODT Tablets 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 does Class II mean?
- Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
- Is this recall still active?
- The FDA lists the recall as ongoing. The recall is still in progress.
Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 12/24/2025 · Do not rely on openFDA to make decisions regarding medical care