Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC
Summary
The FDA issued a Class II for Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose by LEO PHARMA INC. Reason: 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..
Details
Source
Drug Recall
External ID
D-0339-2026
Action Date
2026-03-04
Status
Ongoing
Category
drug
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,
Lot/Code Info: Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Quantity Affected: 11,407 units
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.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-10
Company
Madison, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 39 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LEO PHARMA INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LEO PHARMA INC have FDA actions?
This is the only FDA action we have on record for LEO PHARMA INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0339-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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