The Recall Desk
HighFDA (Drugs)·D-0097-2026·Announced 2025-10-29

Drug vials recalled due to lack of sterility assurance

Bristol-Myers Squibb is recalling 12,778 vials of Opdualag (an immunotherapy drug) nationwide due to lack of assured sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving a sterility assurance defect in an injectable immunotherapy drug. The source does not report any illnesses or hospitalizations. Following the rubric, a Class II recall without reported hospitalization rises only to High (score 3), not Severe (score 4).

Plain-English summary

Bristol-Myers Squibb Company is recalling 12,778 single-dose vials of Opdualag (nivolumab and relatlimab-rmbw) injection. The drug is administered intravenously and is used as an immunotherapy treatment. The recalled product is from lot 033A23B with an expiration date of April 30, 2026.

The recall was initiated due to lack of assurance of sterility. As an injectable product administered directly into the bloodstream, sterility is essential to prevent serious complications.

The affected vials were distributed nationwide throughout the United States. Healthcare providers who have received vials from the affected lot should not administer them and should contact the manufacturer for guidance on replacement product.

The recalled product

Product
OPDUALAG (NIVOLUMAB AND RELATLIMAB-RMBW)
Brand
OPDUALAG
Manufacturer
Bristol-Myers Squibb Company
Category
Drug
Hazard
  • contamination
  • infection

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category