Why it was recalled
Lack of Assurance of Sterility.
Product description
Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11
Lot numbers, UPCs & expiration codes
Lot: 033A23B, Expiry: 4/30/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0097-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 21, 2025
- FDA report date
- Oct 29, 2025
- Quantity
- 12,778 total vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bristol-Myers Squibb Company
Original FDA data
Every field from FDA enforcement report D-0097-2026, exactly as published.
Show all FDA fields
- City
- New Brunswick
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97839
- Address
- 1 Squibb Dr
- Code information
- Lot: 033A23B, Expiry: 4/30/2026
- Postal code
- 08901-1588
- Report date
- Oct 29, 2025
- Product type
- Drugs
- Recall number
- D-0097-2026
- Classification
- Class II
- Recalling firm
- Bristol-Myers Squibb Company
- Product quantity
- 12,778 total vials
- Reason for recall
- Lack of Assurance of Sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 21, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 23, 2025