Opdualag Injection
FDA Recall NDC 0003-7125
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Opdualag (NDC 0003-7125). A significant event, classified as Class II, was initiated on Oct 21, 2025 by E.r. Squibb & Sons, L.l.c.. The reported reason for this action was: "Lack of Assurance of Sterility."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility.
Oct 21, 2025
Oct 29, 2025
12,778 total vials
Recall Profile & Regulatory Data
Event ID
97839
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Bristol-Myers Squibb Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# Lot: 033A23B, Expiry: 4/30/2026
Affected Packages Involved in this Recall
0003-7125-11Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
