Reported Mar 4, 2026 · Ongoing

Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC…

Leo Pharma Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: LEO PHARMA INC · 7 Giralda Farms · Madison, NJ · 07940-1051

Is this the product you have?

  • Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only
  • Manufactured by
    • LEO Pharma A/S. Industriparken 55
    • DK-2750 Ballerup
    • Denmark
  • Distributed byLEO Pharma Inc., Madison, NJ 07940, USA
Lot codes and dates
  • Lot
    • a) 003E24C
    • Exp 04/30/2027
    • b) 003E24A
    • Exp 04/30/2027
Amount recalled
11,407 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:05 PM UTC

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