Recalls / Class II
Class IID-0246-2026
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 name
- Ondansetron
- Generic name
- Ondansetron
- Active ingredient
- Ondansetron Hydrochloride
- Route
- Oral
- NDCs
- 68462-105, 68462-106, 68462-157, 68462-158
- FDA application
- ANDA077535
- Affected lot / code info
- Lot #: 19251311, Exp Date April 2027
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.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 619 River Dr, N/A, Elmwood Park, New Jersey 07407-1317
Distribution
- Quantity
- 96,948 packs
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2025-12-30
- FDA classified
- 2025-12-31
- Posted by FDA
- 2026-01-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0246-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.