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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About This Product

Ondansetron Orally Disintegrating Tablets are used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery. Consumers typically purchase this product to manage nausea effectively.

Why This Is Dangerous

The hazard arises from the blister packs being inadequately sealed, which can cause tablets to fall out. This defect can lead to improper dosing or ingestion, posing a risk to patients.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects consumers by necessitating the immediate cessation of use, which may disrupt their treatment plans. It raises safety concerns regarding the integrity of medication packaging.

Practical Guidance

How to identify if yours is affected

  1. Locate the lot number on the packaging: Lot #: 19251311.
  2. Check the expiration date: April 2027.
  3. If your product matches these details, it is part of the recall.

Where to find product info

The lot number and expiration date are typically found on the bottom or back of the product packaging.

What timeline to expect

Refund or replacement processing may take 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Document all communications with Glenmark Pharmaceuticals.
  • Contact the FDA if you do not receive a timely response.

How to prevent similar issues

  • Always check packaging for seals and integrity before use.
  • Consult with your healthcare provider about alternative medications.
  • Stay informed about recalls in the healthcare sector.

Documentation advice

Keep receipts, correspondence with the company, and photos of the product as evidence.

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.

Key Facts

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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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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