HIGH

Glenmark Pharmaceuticals Recalls Ondansetron Tablets Over Packaging Issues

Glenmark Pharmaceuticals recalled nearly 97,000 packs of Ondansetron Orally Disintegrating Tablets on December 30, 2025. Defective blister packs may not fully seal, leading to tablets falling out. Consumers should stop using the product immediately and contact healthcare providers.

Quick Facts at a Glance

Recall Date
December 30, 2025
Hazard Level
HIGH
Brands
ONDANSETRON, Glenmark Pharmaceuticals Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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 You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Glenmark Pharmaceuticals Inc., USA or your healthcare provider for guidance. Notification method: Letter

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Product Details

ONDANSETRON Orally Disintegrating Tablets, USP, 4mg are packaged in boxes containing 30 tablets (3 blistercards with 10 tablets each). The product is manufactured for Glenmark Pharmaceuticals Inc., USA, and sold nationwide in the United States.

The Hazard

The recall stems from defective blister packs that are not fully sealed. This defect poses a risk of tablets falling out, which could lead to improper dosing or ingestion.

Reported Incidents

As of now, there are no reported injuries or incidents associated with this recall. Consumers are advised to stop using the product as a precaution.

What to Do

Stop using the affected product immediately. Contact Glenmark Pharmaceuticals Inc. or your healthcare provider for further guidance. A notification letter will be sent to consumers.

Contact Information

For more information, contact Glenmark Pharmaceuticals Inc. at [insert contact number]. Visit their website for further assistance.

Key Facts

  • Recall date: December 30, 2025
  • Class II recall classification
  • Quantity: 96,948 packs
  • Manufactured in India
  • Lot #: 19251311, Expiration: April 2027

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeOndansetron Orally Disintegrating Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot #: 19251311
UPC Codes
68462-105
68462-106
68462-157
+8 more
Affected States
ALL
Report Date
January 7, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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