HIGHFDA DRUG

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,...

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
June 10, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
June 10, 2026
Hazard Level
HIGH
Brands
IMULDOSA, Accord BioPharma Inc.
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
IMULDOSA, Accord BioPharma Inc.
Model numbers
Lot # 004L24A, Exp Date: 02/19/2027.
UPC codes
69448-017, 69448-018, 69448-019, 69448-018-63, 69448-017-63, 69448-019-26
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    June 10, 2026

  2. Reported by FDA DRUG

    July 8, 2026

  3. RecallRadar source check

    July 14, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Lack of assurance of Sterility:

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact ACCORD BIOPHARMA INC or your healthcare provider for guidance. Notification method: Letter

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Full 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.. Generic: USTEKINUMAB-SRLF; Brand: IMULDOSA. Reason: Lack of assurance of Sterility:. Classification: Class II. Quantity: 326 vials. Distribution: US Nationwide.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lot # 004L24A
Exp Date: 02/19/2027.
UPC Codes
69448-017
69448-018
69448-019
+3 more
Affected States
ALL
Report Date
July 8, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE