D-0246-2026 Class II Ongoing
FDA drug recall D-0246-2026 was initiated by Glenmark Pharmaceuticals Inc., USA on December 30, 2025 and is designated Class II. 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 purchase… The recall status is ongoing. Affected quantity: 96,948 packs.
Recall Details
- Product Type
- Drugs
- Report Date
- January 7, 2026
- Initiation Date
- December 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96,948 packs
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
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.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 19251311, Exp Date April 2027