FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Drug · Recalled July 8, 2026

IMULDOSA recall — ACCORD BIOPHARMA INC

Hazard: Lack of assurance of Sterility:

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0653-2026
Brand
ACCORD BIOPHARMA
Classification
Class II
Units affected
326 vials
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.

Affected products

Companies & origin

Recalling firm location
Raleigh, NC, United States
Firm address
8041 Arco Corporate Dr Ste 200, N/A, 27617-2091

Identifying details (verbatim from the notice)

Product codes / lots
Lot # 004L24A, Exp Date: 02/19/2027.
Distribution
US Nationwide.
Firm notified the public via
Letter
FDA event ID
99216
Recall initiated
June 10, 2026
FDA classified
June 29, 2026
FDA report date
July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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