Bristol Myers Squibb recalls Opdualag (nivolumab and relatlimab-rmbw) injection vials with lack of sterility assurance. This recall affects single-dose vials sold between 2023 and 2026. No remedy is specified in the official notice.
Lack of Assurance of Sterility.
Bristol Myers Squibb has recalled Opdualag injections due to a lack of assurance of sterility. This means the product could be contaminated, posing a risk of infection if used. The recall affects specific vial sizes and lots sold through pharmacies.
The product lacks assurance of sterility, meaning it could be contaminated with bacteria or other pathogens. If injected, this could lead to serious infections or other health complications. The risk is specific to the injection product and not applicable to other forms of the medication.
Patients prescribed Opdualag injections by healthcare providers are affected. Those using the recalled vials (240 mg and 80 mg/20 mL) are at risk of infection from potential contamination.
Check for Opdualag (nivolumab and relatlimab-rmbw) injection vials labeled 240 mg and 80 mg/20 mL (12mg and 4mg/mL). The recall includes vials with lot number 033A23B and expiration date 4/30/2026.
Identify if your Opdualag injection vial has the lot number 033A23B and expiration date 4/30/2026.
The official notice does not specify a remedy.
The product lacks assurance of sterility, which could lead to contamination and infection if used.
Look for Opdualag injection vials with lot number 033A23B and expiration date 4/30/2026.
We’ve drafted a message you can send Bristol Myers Squibb to request your refund or repair — edit it as you like.
Subject: Recall D-0097-2026 — Bristol Myers Squibb Bristol Myers Squibb Hello, I own a Bristol Myers Squibb that is covered by recall D-0097-2026 from Bristol Myers Squibb. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
