FDA Drug recall D-0339-2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91
- FDA Drug
- Class II
- ongoing
- Published 2026-03-04
On 2026-03-04 the FDA classified a Class II recall of Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91 by Leo Pharma, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0339-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-10 |
| Published | 2026-03-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Leo Pharma |
| Distribution | US |
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.
Identifiers
| ndc | 50222-346-01 |
|---|---|
| ndc | 50222-346-02 |
| ndc | 50222-346-22 |
| ndc | 50222-346-04 |
| ndc | 50222-346-91 |
| ndc | 50222-346-92 |
| ndc | 50222-350-00 |
| ndc | 50222-350-01 |
| ndc | 50222-350-02 |
| ndc | 50222-350-90 |
| ndc | 50222-350-91 |
| code_info | Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0339-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.