Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SA...
FDA Recall #D-0339-2026 — Class II — February 10, 2026
Product Description
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,
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.
Recalling Firm
LEO PHARMA INC — Madison, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
11,407 units
Distribution
Nationwide in the USA
Code Information
Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated