Home / Recalls / Bristol-Myers Squibb Company / D-0097-2026

D-0097-2026 Class II Ongoing

Recalled by Bristol-Myers Squibb Company — New Brunswick, NJ

Recall Details

Product Type
Drugs
Report Date
October 29, 2025
Initiation Date
October 21, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,778 total vials

Product Description

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

Reason for Recall

Lack of Assurance of Sterility.

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 033A23B, Expiry: 4/30/2026

Other recalls by Bristol-Myers Squibb Company

  • D-0959-2017 Class I — EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb (June 5, 2017)
  • D-012-2013 Class I — BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured (August 29, 2012)
  • D-019-2013 Class II — Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physicia (June 5, 2012)
  • D-018-2013 Class II — Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physicia (June 5, 2012)