FDA Drugs recall ·
Ondansetron Orally Disintegrating Tablets, USP, 4mg… recall
- Recall number
- D-0246-2026
- Date
- (initiated December 30, 2025)
- Company / brand
- Glenmark Pharmaceuticals Inc., USA
619 River Dr, Elmwood Park, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 96,948 packs
- Hazard tags
- Fall
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13
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 #: 19251311, Exp Date April 2027
Distribution
Nationwide within the United States
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-0246-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.