Bristol-Myers Squibb recalled 12,778 vials of Opdualag injection on October 21, 2025. The recall stems from a lack of assurance of sterility. The affected products were distributed nationwide in the United States.
Lack of Assurance of Sterility.
Consumers and healthcare providers should stop using this product immediately. Contact Bristol-Myers Squibb Company or your healthcare provider for guidance. Notification method: Letter
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Opdualag injection (Nivolumab and Relatlimab-rmbw) comes in 240 mg and 80 mg/20 mL single-dose vials. The recalled lot number is 033A23B, with an expiration date of April 30, 2026.
The recall is due to a lack of assurance of sterility, which poses a high risk of infection. Sterility is critical for injectable medications.
No specific incidents of injury or illness have been reported related to this recall. The lack of sterility could potentially lead to serious health risks.
Stop using the Opdualag injection immediately. Contact Bristol-Myers Squibb or your healthcare provider for further guidance.
For assistance, call Bristol-Myers Squibb at 1-800-XXX-XXXX or visit their website for more information.
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