# FDA recall D-0339-2026

> **LEO PHARMA INC** · Class II · drug recall initiated 2026-02-10.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0339-2026
- **Recalling firm:** LEO PHARMA INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-02-10
- **Report date:** 2026-03-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Madison, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0339-2026

## Citation

> AI Analytics. FDA recall D-0339-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0339-2026. Source: US FDA. Licensed CC0.

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