FDAHealthFebruary 10, 2026
LEO PHARMA INC — 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-
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 10, 2026
Nationwide in the USA
What's affected?
- Product
- 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,
- Brand
- ADBRY
- Lot code
- a)
Additional details
Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 11,407 units.
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