October 2025 FDA Recall Opdualag by Bristol-myers Squibb Company
D-0097-2026 - Lack of Assurance of Sterility.
This Class II drug recall was voluntarily initiated by Bristol-myers Squibb Company on October 21, 2025 for the product Opdualag. The FDA reported the reason for recall as lack of assurance of sterility.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0097-2026
Lack of Assurance of Sterility.
10-21-2025
10-29-2025
12,778 total vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Bristol-Myers Squibb Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
