Why it was 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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 19251311, Exp Date April 2027
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0246-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 30, 2025
- FDA report date
- Jan 7, 2026
- Quantity
- 96,948 packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0246-2026, exactly as published.
Show all FDA fields
- City
- Elmwood Park
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98233
- Address
- 619 River Dr
- Code information
- Lot #: 19251311, Exp Date April 2027
- Postal code
- 07407-1317
- Report date
- Jan 7, 2026
- Product type
- Drugs
- Recall number
- D-0246-2026
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 96,948 packs
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 30, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 31, 2025