Adbry — Class II drug recall D-0339-2026
Ongoing recall by LEO PHARMA INC, reported 2026-03-04, distributed nationwide. Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab
| Recall number | D-0339-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LEO PHARMA INC, Madison, NJ, United States |
| Recall initiated | 2026-02-10 |
| Classified | 2026-02-23 |
| Reported by FDA | 2026-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 11,407 units |
| Reason classes | sterility, specification failure |
| NDC | 50222-0346, 50222-0346-01, 50222-0346-02, 50222-0346-04, 50222-0346-22, 50222-0346-91, 50222-0346-92, 50222-0350, 50222-0350-00, 50222-0350-01, 50222-0350-02, 50222-0350-90, 50222-0350-91 |
| Expiration dates | 2027-04-30 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0339-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.