Limited official informationFDA Drug Enforcement ReportsRecall date: Jul 8, 2026

IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arc...

Full official 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.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Identifiers to compare

NDC 69448-019-26
Lot 004L24A

Affected variants from the official event record
Product or model	Codes and lots	Quantity	Recall number
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, S...	Lot # 004L24A, Exp Date: 02/19/2027.	326 vials	D-0653-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Lack of assurance of Sterility:

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

U.S. Food and Drug Administration authoritative
openFDA Drug authoritative

Official scope

Distribution reported by the agency

US Nationwide.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.