Opdualag (nivolumab and relatlimab-rmbw) injection recall
FDA recall D-0097-2026 · initiated Oct 21, 2025
Bristol-Myers Squibb Company recalled Opdualag (nivolumab and relatlimab-rmbw) injection in Oct 2025 — an FDA Class II recall (D-0097-2026) because Lack of Assurance of Sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 12,778 total vials
Details
- Product
- 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
- Recalling company
- Bristol Myers Squibb
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Oct 21, 2025
- FDA report date
- Oct 29, 2025
This recall is linked to a product we cover: Opdualag →
Frequently asked
- Was Opdualag (nivolumab and relatlimab-rmbw) injection recalled?
- Bristol-Myers Squibb Company recalled Opdualag (nivolumab and relatlimab-rmbw) injection in Oct 2025 — an FDA Class II recall (D-0097-2026) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Opdualag (nivolumab and relatlimab-rmbw) injection recalled?
- Per the FDA enforcement record, the reason for recall D-0097-2026 was: Lack of Assurance of Sterility.
- Is a recalled Opdualag (nivolumab and relatlimab-rmbw) injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Opdualag (nivolumab and relatlimab-rmbw) injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot: 033A23B, Expiry: 4/30/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0097-2026.