Warning
ACCORD BIOPHARMA INC Recalls IMULDOSA
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0653-2026Drug / Pharmaceutical
ACCORD BIOPHARMA INC Recalls IMULDOSA
ACCORD BIOPHARMA INC · Class II — Moderate Risk
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.
Reason for Recall
Lack of assurance of Sterility:
FDA Classification
Class II — Moderate Risk
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.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. ACCORD BIOPHARMA INC initiated the recall on June 10, 2026 affecting 326 vials. Lack of assurance of Sterility:. The product was distributed in US Nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact ACCORD BIOPHARMA INC for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.