FDA recall D-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

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

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2025-12-30

Report date

2026-01-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elmwood Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0246-2026