CLASS II ONGOING Drug recall · Reported 29 Oct 2025 · FDA Enforcement Report
Opdualag (nivolumab and relatlimab-rmbw) injection recalled
Bristol-Myers Squibb is recalling Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/ (12mg and 4mg/mL), distributed nationwide in the US. The recall was initiated on 21 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0097-2026
- FDA event ID
- 97839
- Recalling firm
- Bristol-Myers Squibb, New Brunswick, NJ
- Brand
- Opdualag
- Manufacturer
- E.R. Squibb & Sons, L.L.C.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Oct 2025
- FDA classified
- 23 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Oct 2025 | Recall initiated by company | |
| 23 Oct 2025 | Classified by FDA | +2 days |
| 29 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/ (12mg and 4mg/mL) recalled?
Yes. Bristol-Myers Squibb recalled Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/ (12mg and 4mg/mL) on 21 Oct 2025. The recall is Class II and its status is Ongoing. Recall number D-0097-2026.
Why was it recalled?
Lack of Assurance of Sterility.
Which lots are affected?
Lot: 033A23B, Expiry: 4/30/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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