The medication's targeted to help a particularly vulnerable group, but now there's an apparent "lack of assurance of sterility."
Every year, around 104,960 people are diagnosed with melanoma, a potentially life-threatening form skin cancer that starts in the skin’s melanin-forming cells—and the American Cancer Society estimates that 8,430 individuals will die from the condition this year in the U.S. Thankfully, new advancements in immunotherapy and other targeted therapies are lengthening lifespans and offering profound hope to those who have received a melanoma diagnosis. However, a new nationwide recall serves as a reminder of the importance of ongoing safety monitoring and transparent communication between patients, physicians, and regulators.
According to an October 23 safety notice from the U.S. Food and Drug Administration (FDA), a total of 12,778 vials of the immunotherapy drug Opdualag (nivolumab and relatlimab-rmbw) have been recalled across the country due to “lack of assurance of sterility.” The vials were produced by the global drug manufacturer Bristol-Myers Squibb Company of New Brunswick, New Jersey.
Sterility is an important safety measure in any medication, but it’s especially crucial to the safety of injectable and IV-infused drugs. According to the U.S. Centers for Disease Control and Prevention (CDC), single dose vials, potentially like the ones that were recalled, “typically lack an antimicrobial preservative.” This makes them more vulnerable to contamination, and “Improper reuse of [single dose vials] has caused patient infections and deaths,” says the agency.
Opdualag is used in the treatment of advanced stage or metastatic melanoma skin cancer. According to the American Cancer Society, it’s a single-dose checkpoint inhibitor—a medication that works by blocking “checkpoint” proteins on immune cells, thereby preventing the immune system from attacking healthy cells. It can also “help the immune system find and attack melanoma cells,” their experts write. Put even more simply on the drug manufacturer’s website: “Your immune system has T cells that attack cancer cells, but T cells can get tired. Two immunotherapies connect to some T cells and work in sync to activate them.”
The FDA provided the following identifying details in its report:
- Product Name: Opdualag (nivolumab and relatlimab-rmbw) Injection
- Single dose vial, Rx only
- Strength: 240 mg and 80 mg / 20 mL (12 mg and 4 mg per mL)
- NDC (National Code): 0003-7125-11
- Exp. Date: 4/30/2026
The National Cancer Institute adds that Opdualag is the first drug approved by the FDA to target a specific protein on immune cells, called LAG-3. Administered once every four weeks by IV infusion in a clinical setting, it is approved for use in adults and children over the age of 12 who have been diagnosed with advanced melanomas, or those that can’t be removed by surgery.
The FDA has labeled the recall incident a Class II event, indicating it’s “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
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