⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

DrugsSource: FDA (drug) · Date: 2026-03-04

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
LEO PHARMA INC
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 / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-02-10
Code info
Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Product quantity
11,407 units
Voluntary mandated
Voluntary: Firm initiated
City
Madison
State
NJ
Country
United States
Event id
98401
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