FDA recall, , Moderate risk
Adbry (Tralokinumab-Ldrm) Injection
Adbry injection may not be sterile due to wool fiber particulate matter in one unit.
Summary by Recall Canary from the FDA notice
What happened
LEO Pharma Inc., of Madison, New Jersey, began a recall on February 10, 2026, of Adbry (tralokinumab-ldrm) injection, 300 mg/2mL, because the agency cited a lack of assurance of sterility due to the presence of particulate matter in one unit from the lot, which lab tests identified as wool fiber. The product is packaged as a single-dose autoinjector sample not for sale and as two single-dose autoinjectors, and is distributed nationwide in the USA.
The recall was added to the FDA's Enforcement Report and classified on February 23, 2026, and was in the FDA's weekly enforcement report on March 4, 2026. The agency noted the product is manufactured by LEO Pharma A/S in Denmark and distributed by LEO Pharma Inc. in Madison, New Jersey. The recall covers 11,407 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its NDC and lot code are listed under that product.
An NDC (National Drug Code) is usually printed on the drug's label.
Adbry (tralokinumab-ldrm) injection
- NDC
- 50222-350-91
- 50222-350-02
- Lot code
- 003E24C
- 003E24A
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- LEO PHARMA INCMadison, New Jersey
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98401
- Recall number
- D-0339-2026
- Quantity recalled
- 11,407 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
