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
Locate the lot number on the packaging: Lot #: 19251311.
Check the expiration date: April 2027.
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.
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