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Class II · ModerateActive recall

Ondansetron

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 19251311, Exp Date April 2027
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGlenmark Pharmaceuticals Inc., USA
Brand nameONDANSETRON
Generic nameONDANSETRON
Active ingredient(s)ONDANSETRON HYDROCHLORIDE
Distributed by / forGlenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India
NDC68462-157-13
Show the full FDA record
Full product labelOndansetron 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
Recalling firmGlenmark Pharmaceuticals Inc., USA
DistributionNationwide within the United States
Quantity96,948 packs
Recall initiated2025-12-30
Report date2026-01-07
Recall completed—
Recall numberD-0246-2026
ClassificationClass II
FDA statusOngoing
Origin on fileElmwood Park NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.