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Drug FDA Class II Ongoing Contamination / non-sterility

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

Bristol-Myers Squibb Company Published Oct 29, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Bristol-Myers Squibb Company or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility.

Hazards

Lack of Sterility Assurance · primary

Affected products (1)

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

OPDUALAG · 12,778 total vials

NDC: 0003-7125, 0003-7125-11
Lot codes: 033A23B
Code info: Lot: 033A23B, Expiry: 4/30/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 21, 2025
  2. Published
    Oct 29, 2025
Recall number
D-0097-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.