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
Ondansetron Recall Summary Glenmark Pharmaceuticals is recalling 4mg ondansetron orally disintegrating tablets (30-tablet packages) distributed nationwide because the blister pack seals are defective and tablets are falling out of the packaging. This is a Class I recall affecting all U.S. states and Washington, D.C. The affected product was manufactured in India and has NDC number 68462-157-13.
- Recalling firm
- 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 I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-12-30
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/35dfdb6e-f4fe-486a-a935-fb86ade7c53b