Drug recall D-0339-2026

Class II Ongoing reported Mar 4, 2026

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,

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.

Lots and codes

Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.

Recall details

Recalling firm
LEO PHARMA INC, Madison, NJ
Quantity
11,407 units
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
February 10, 2026

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