HIGH

LEO Pharma Recalls Adbry Injection Over Sterility Concerns

LEO Pharma Inc. recalled 11,407 units of Adbry injection on February 10, 2026. The recall stems from a lack of assurance of sterility due to particulate matter identified as wool fiber. Consumers should stop using the product immediately and contact their healthcare provider for guidance.

Quick Facts at a Glance

Recall Date
February 10, 2026
Hazard Level
HIGH
Brands
ADBRY, LEO Pharma Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact LEO PHARMA INC or your healthcare provider for guidance. Notification method: E-Mail

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About This Product

Adbry is an injection used primarily for the treatment of eczema. Patients often purchase this medication because it is effective in managing symptoms and providing relief.

Why This Is Dangerous

The presence of wool fiber in the injection raises serious concerns about sterility and potential contamination, which can lead to infections or other health issues.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers must stop using the product immediately, as continued use could pose serious health risks due to potential contamination.

Practical Guidance

How to identify if yours is affected

  1. Locate the lot number on your Adbry injection packaging.
  2. Check if it matches the recalled lot numbers: a) 003E24C or b) 003E24A.
  3. Verify the expiration date is 04/30/2027.

Where to find product info

The lot number can be found on the packaging of the product, usually near the expiration date or barcode.

What timeline to expect

Expect a refund processing timeline of 4-6 weeks after contacting LEO Pharma Inc.

If the manufacturer is unresponsive

  • Document all communication attempts with LEO Pharma Inc.
  • Consider filing a complaint with the FDA if no response is received.

How to prevent similar issues

  • Always check for recalls before purchasing medications.
  • Consult healthcare providers for the latest safety information on medications.
  • Be aware of any changes in product appearance or packaging.

Documentation advice

Keep records of your purchase, including receipts and correspondence with the manufacturer.

Product Details

The recall includes Adbry injection, 300 mg/2mL, packaged as 1 x Single dose Autoinjector (NDC 50222-350-91) and 2 x Single dose Autoinjectors (NDC 50222-350-02). The product was distributed nationwide in the USA.

Key Facts

  • Recall date: February 10, 2026
  • Reported date: March 4, 2026
  • Quantity recalled: 11,407 units
  • Class II recall
  • Manufactured by LEO Pharma A/S, Denmark

Safety Guide

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

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot: a) 003E24C
Exp 04/30/2027
b) 003E24A
Exp 04/30/2027.
UPC Codes
50222-346
50222-350
50222-346-01
+9 more
Affected States
ALL
Report Date
March 4, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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