Tralokinumab Recall: Adbry autoinjector
Announced 2026-03-04 · FDA
The FDA recall concerns Adbry (tralokinumab-ldrm) injections due to lack of assurance of sterility; one unit contained wool fiber. The recall covers 11,407 units nationwide across two lots, 003E24C and 003E24A, expiring 04/30/2027. No corrective action is specified.
| 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 | 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. |
| Severity | moderate |
| Units affected | 11407 |
| Distribution | Nationwide in the USA |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use Adbry autoinjectors from the recalled lots (003E24C or 003E24A).
- Check the packaging/label on your product to determine if you own an affected unit; if so, stop using it and contact your healthcare provider for guidance.
- Return the product to the place of purchase or follow disposal/replacement instructions from your healthcare provider or the recall notice.
- For more information, visit the FDA recall page or contact LEO Pharma consumer information.
How to identify the recalled item
| Lot / date codes | Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027. |
|---|---|
| Lot / date codes | Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.