Recalls / Class II
Class IID-0339-2026
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,
- Brand name
- Adbry
- Generic name
- Tralokinumab-ldrm
- Active ingredient
- Tralokinumab
- Route
- Subcutaneous
- NDCs
- 50222-346, 50222-350
- FDA application
- BLA761180
- Affected lot / code info
- Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Why it was recalled
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.
Recalling firm
- Firm
- LEO PHARMA INC
- Manufacturer
- LEO Pharma Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 7 Giralda Farms, N/A, Madison, New Jersey 07940-1051
Distribution
- Quantity
- 11,407 units
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2026-02-10
- FDA classified
- 2026-02-23
- Posted by FDA
- 2026-03-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0339-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.