FDAFDA · Food and drugs·Recall number 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; 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,
Published March 4, 2026 · Recall initiated: February 10, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- ADBRY
- Manufacturer
- LEO PHARMA INC
- Distributor
- Nationwide in the USA
- Lot
- Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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