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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ONDANSETRON, Glenmark Pharmaceuticals Inc.
- Product type
- Ondansetron Orally Disintegrating Tablets
- Model numbers
- Lot #: 19251311
- UPC codes
- 68462-105, 68462-106, 68462-157, 68462-158, 68462-105-33, 68462-105-30, 68462-106-33, 68462-106-30 +3 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 30, 2025
Reported by FDA DRUG
January 7, 2026
RecallRadar source check
January 14, 2026
Consumer action
Use the official remedy and keep documentation.
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
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.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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
- Manufactured in India
- Lot #: 19251311, Expiration: April 2027
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.