Bristol-Myers Squibb recalled 12,778 Opdualag single-dose vials nationwide after a lack of assurance of sterility was identified. The product is nivolumab and relatlimab-rmbw injection. The recall date is 2025-10-21. Healthcare providers should stop using affected lots and follow the recall letter guidance.
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 is a prescription cancer immunotherapy consisting of nivolumab and relatlimab-rmbw. It is administered via intravenous injection and is distributed through healthcare channels to patients under medical supervision.
The product was recalled due to lack of assurance of sterility, which could lead to contamination and infection risks if administered.
This recall is not stated as part of a broader industry pattern.
Hospitals and clinics must identify affected lots, quarantine vials, and follow recall guidance. The issue could impact patient safety and supplies in oncology treatment settings.
FDA recall page and manufacturer communications; official recall letter
Recall communications will be issued to healthcare providers; replacement or guidance timelines will be provided by the manufacturer and FDA
Keep recall letters, lot numbers, NDC, expiry dates, and correspondence with the manufacturer for records
Brand: Opdualag Generic: nivolumab and relatlimab-rmbw NDC: 0003-7125-11 Pack: Single Dose Vial, Rx Only Manufacturer: Bristol-Myers Squibb Company, Princeton, NJ 08543 Quantity recalled: 12,778 vials Lot: 033A23B Expiry: 04/30/2026 Sold nationwide in the USA Recall date: 2025-10-21 Status: Active Reason: Lack of Assurance of Sterility Notes: Distribution nationwide; Rx only; 12,778 total vials with Lot 033A23B
No injuries or incidents have been reported.
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