opdualagdrugHigh PriorityActive

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

opdualag 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 recalled by FDA. Lack of Assurance of Sterility.

By RecallRadar Editorial Team

Sourced from FDA. Last reviewed March 4, 2026.

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source: FDA
Announced by source: October 21, 2025
Last reviewed by RecallRadar: March 4, 2026

What You Should Do

1## 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 Agency: FDA | Category: drug Reason: Lack of Assurance of Sterility. What to do:
2Stop using the product if your lot/model matches.
3Check the FDA notice for specifics.
4Follow remedy instructions.

Open Official Recall Notice Get Alerts for opdualag Devices

What's Being Recalled

Quoted source excerpt from the official notice.

Lack of Assurance of Sterility.

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

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

#	Model
1	Lot: 033A23B, Expiry: 4/30/2026

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

Frequently Asked Questions

Is my opdualag device affected?

Check the affected models section on this page. The official notice currently lists Lot: 033A23B, Expiry: 4/30/2026.

What is the remedy for this recall?

## 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 Agency: FDA | Category: drug Reason: Lack of Assurance of Sterility. What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: opdualag recall hub and Food & Drug recall hub.