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FDA-Drug2026-01-07Class IIPACKAGING DEFECT

Glenmark Ondansetron 4mg tablets recalled for defective blister pack sealing

Glenmark
TAMPERINGNationwide distribution

Stop using Glenmark Ondansetron 4mg tablets

Glenmark Pharmaceuticals discovered that blister packs containing Ondansetron 4mg orally disintegrating tablets are not fully sealed, allowing tablets to fall out. The affected product was repackaged and distributed nationwide. This applies to lot #19251311 with an expiration date of April 2027.

  • Check if you have Glenmark Ondansetron 4mg tablets, lot #19251311, expiration April 2027 (NDC 68462-157-13)
  • Do not use tablets that have fallen out of the blister pack or appear loose
  • Contact your pharmacy or doctor for a replacement or instructions
  • Do not flush tablets down the toilet unless instructed to do so
Hazard

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.

Sold states
Nationwide within the United States
Affected count
96,948 packs
Manufactured in
619 River Dr, N/A, Elmwood Park, NJ, United States
Products
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

Official notice

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

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