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 |
| Recall / campaign no. | Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027. |
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.
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.