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Class II · ModerateActive recall

Adbry

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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 to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA
Brand nameADBRY
Generic nameTRALOKINUMAB-LDRM
Active ingredient(s)TRALOKINUMAB
Distributed by / forLEO Pharma Inc., Madison, NJ 07940, USA
NDC50222-350-91
Show the full FDA record
Full product labelAdbry, (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,
Recalling firmLEO PHARMA INC
DistributionNationwide in the USA
Quantity11,407 units
Recall initiated2026-02-10
Report date2026-03-04
Recall completed—
Recall numberD-0339-2026
ClassificationClass II
FDA statusOngoing
Origin on fileMadison NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.