Glenmark Pharmaceuticals Inc., USA recalls Ondansetron Orally Disintegrating Tablets
- Recalling company
- Glenmark Pharmaceuticals Inc., USA
- 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
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 30, 2025
- Reported
- Jan 7, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- 96,948 packs
- Lot / codes
- Lot #: 19251311, Exp Date April 2027
- Company location
- Elmwood Park, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0246-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0246-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.