FDAHealthDecember 30, 2025
Glenmark Pharmaceuticals Inc., USA — Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals In
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 30, 2025
Nationwide within the United States
What's affected?
- 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
- Brand
- ONDANSETRON
- UPC
- 0368462157138
- Lot code
- 19251311
Additional details
Lot #: 19251311, Exp Date April 2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 96,948 packs.
Get Health recall alerts
Delivered to your inbox. Free. No account required.