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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Adbry (tralokinumab-ldrm) Injection Recalled for Sterility Concerns

Agency Publication Date: February 23, 2026
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Summary

LEO PHARMA INC is recalling approximately 11,407 units of Adbry (tralokinumab-ldrm) 300 mg/2mL injections because a wool fiber was found inside one unit. While only one unit was reported to contain the fiber, the issue creates a lack of assurance that the entire batch remains sterile. Adbry is used to treat moderate-to-severe atopic dermatitis (eczema) and was distributed nationwide in the United States.

Risk

The presence of foreign particulate matter like wool fiber in an injectable medication can compromise sterility, potentially leading to serious infections or localized inflammatory reactions at the injection site.

What You Should Do

  1. Check your Adbry (tralokinumab-ldrm) packaging for lot numbers 003E24C or 003E24A, both with an expiration date of 04/30/2027.
  2. If you have health concerns, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact LEO PHARMA INC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Adbry (tralokinumab-ldrm) injection (300 mg/2mL)
Variants: 1 x Single dose Autoinjector (SAMPLE), 2 x Single dose Autoinjectors
Lot Numbers:
003E24C (Exp 04/30/2027)
003E24A (Exp 04/30/2027)
NDC:
50222-350-91
50222-350-02

Rx only; Manufactured by LEO Pharma A/S in Denmark; Distributed by LEO Pharma Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98401
Status: Active
Manufacturer: LEO PHARMA INC
Sold By: Retail Pharmacies; Physician Offices (Samples)
Manufactured In: Denmark
Units Affected: 11,407 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.