← FDA ENFORCEMENT
D-0653-2026Class II

ACCORD BIOPHARMA INC

Recalling firm
ACCORD BIOPHARMA INC
Product type
Drug
Status
Ongoing
Report date
2026-07-08
Distribution
US Nationwide.
Firm state
NC
Product quantity
326 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of assurance of Sterility:

Product 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.

Code / lot info

Lot # 004L24A, Exp Date: 02/19/2027.

Other recalls SPEQ maps to Environmental Monitoring
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See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.