Opdualag injection vials recalled from one lot over sterility assurance
Bristol-Myers Squibb is recalling 12,778 vials of Opdualag (nivolumab and relatlimab-rmbw) injection from one lot for lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a loss of sterility assurance in an injectable creates an infection risk, and no injuries are reported.
Plain-English summary
Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL, in single dose vials from Bristol-Myers Squibb of Princeton, New Jersey, is being recalled for lack of assurance of sterility.
The recall covers 12,778 vials from lot 033A23B, expiring 30 April 2026, carrying NDC 0003-7125-11. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
Sterility matters for an injectable because the product is administered directly into the body. The enforcement record describes a loss of sterility assurance rather than confirmed contamination, and reports no injuries.
Facilities holding the affected lot should quarantine it and follow the firm's instructions.
The recalled product
- Product
- OPDUALAG (NIVOLUMAB AND RELATLIMAB-RMBW)
- Brand
- OPDUALAG
- Manufacturer
- Bristol-Myers Squibb Company
- Category
- Drug — Injectable
- Affected units
- 12,778
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 033A23B
- Expiry: 4/30/2026
Distribution
Distributed nationwide across the United States.
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