Medications & Supplements/Prescription Drugs

Opdualag Injection Recalled for Lack of Assurance of Sterility

Agency Publication Date: October 23, 2025

Summary

Bristol-Myers Squibb Company is recalling 12,778 vials of Opdualag (nivolumab and relatlimab-rmbw) injection. The recall was initiated because the manufacturer cannot guarantee the sterility of the medication. This drug is used as a prescription injection, and patients should contact their healthcare provider immediately for guidance regarding their treatment.

Risk

A lack of sterility assurance means the medication may be contaminated with microorganisms. Injecting a non-sterile drug can lead to serious, potentially life-threatening infections at the injection site or throughout the body.

What You Should Do

Check your medication for Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL) single-dose vials with NDC 0003-7125-11.
Identify if you have lot number 033A23B with an expiration date of 4/30/2026 printed on the vial or carton.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Opdualag (nivolumab and relatlimab-rmbw) injection (20 mL)

Variants: 240 mg and 80 mg/20 mL (12mg and 4mg/mL), Single Dose Vial, RX Only

Lot Numbers:

033A23B (Exp 4/30/2026)

NDC:

0003-7125-11

Recall #: D-0097-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97839

Status: Active

Manufacturer: Bristol-Myers Squibb Company

Sold By: Wholesalers; Hospitals; Clinics

Manufactured In: United States

Units Affected: 12,778 total vials

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication for Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL) single-dose vials with NDC 0003-7125-11.

Identify if you have lot number 033A23B with an expiration date of 4/30/2026 printed on the vial or carton.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.