Adbry Injection, Solution
FDA Recall NDC 50222-346
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Adbry (NDC 50222-346). A significant event, classified as Class II, was initiated on Feb 10, 2026 by Leo Pharma Inc.. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
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.
Feb 10, 2026
Mar 04, 2026
11,407 units
Recall Profile & Regulatory Data
Event ID
98401
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
LEO PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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,
Batch or Lot Expiration Information
Lot# Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Affected Packages Involved in this Recall
50222-346-01Product
50222-346-02Product
50222-346-22Product
50222-346-04Product
50222-346-91Product
50222-346-92Product
50222-350-00Product
50222-350-01Product
50222-350-02Product
50222-350-90Product
50222-350-91Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
