Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only,
Summary
The FDA issued a Class II for Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg by Bristol-Myers Squibb Company. Reason: Lack of Assurance of Sterility..
Details
Source
Drug Recall
External ID
D-0097-2026
Action Date
2025-10-29
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot: 033A23B, Expiry: 4/30/2026
Quantity Affected: 12,778 total vials
Reason for Recall
Lack of Assurance of Sterility.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-21
Company
New Brunswick, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 58 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bristol-Myers Squibb Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bristol-Myers Squibb Company have FDA actions?
This is the only FDA action we have on record for Bristol-Myers Squibb Company in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0097-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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