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Drug FDA Class II Ongoing Foreign material

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 by: LEO Pharm

LEO PHARMA INC Published Mar 4, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact LEO PHARMA INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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.

Hazards

Wool Fiber · primary

Affected products (1)

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 by: LEO Pharma Inc., Madison, NJ 07940, USA,

ADBRY · 11,407 units

NDC: 50222-346, 50222-350, 50222-346-01, 50222-346-02, 50222-346-22, 50222-346-04, 50222-346-91, 50222-346-92, 50222-350-00, 50222-350-01, 50222-350-02, 50222-350-90, 50222-350-91
Code info: Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 10, 2026
  2. Published
    Mar 4, 2026
Recall number
D-0339-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.