Quick Facts at a Glance
- Recall Date
- October 21, 2025
- Hazard Level
- HIGH
- Brands
- Opdualag, Bristol-Myers Squibb
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, GENERAL, 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
- Opdualag, Bristol-Myers Squibb
- Product type
- Intravenous monoclonal antibody injection
- Model numbers
- 033A23B
- UPC codes
- 0003-7125, 0003-7125-11
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 21, 2025
Reported by FDA DRUG
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Bristol-Myers Squibb Company or your healthcare provider for guidance. Notification method: Letter
About This Product
Opdualag is a prescription cancer immunotherapy consisting of nivolumab and relatlimab-rmbw. It is administered via intravenous injection and is distributed through healthcare channels to patients under medical supervision.
Why This Is Dangerous
The product was recalled due to lack of assurance of sterility, which could lead to contamination and infection risks if administered.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must identify affected lots, quarantine vials, and follow recall guidance. The issue could impact patient safety and supplies in oncology treatment settings.
Practical Guidance
How to identify if yours is affected
- Check NDC 0003-7125-11 on the vial label
- Verify Lot 033A23B
- Ensure stock was distributed nationwide in the USA
- Isolate any suspected vials and follow recall procedures
Where to find product info
FDA recall page and manufacturer communications; official recall letter
What timeline to expect
Recall communications will be issued to healthcare providers; replacement or guidance timelines will be provided by the manufacturer and FDA
If the manufacturer is unresponsive
- Escalate to hospital risk management or a regulatory contact
- File an FDA recall report if institutional processes fail
- Consult legal counsel if patient harm occurs
How to prevent similar issues
- Implement strict lot-tracking for sterile injectables
- Verify lot numbers before administration
- Establish quarantine procedures for recalled lots
- Maintain clear recall communication channels with suppliers
Documentation advice
Keep recall letters, lot numbers, NDC, expiry dates, and correspondence with the manufacturer for records
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Product Details
Brand: Opdualag Generic: nivolumab and relatlimab-rmbw NDC: 0003-7125-11 Pack: Single Dose Vial, Rx Only Manufacturer: Bristol-Myers Squibb Company, Princeton, NJ 08543 Quantity recalled: 12,778 vials Lot: 033A23B Expiry: 04/30/2026 Sold nationwide in the USA Recall date: 2025-10-21 Status: Active Reason: Lack of Assurance of Sterility Notes: Distribution nationwide; Rx only; 12,778 total vials with Lot 033A23B
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 12,778 total vials recalled
- Lot 033A23B
- Nationwide US distribution
- High-hazard sterility issue
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Safety Guide
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