FDA Class II Recall Issued for Tralokinumab-ldrm Injection Over Sterility Concern

Key Takeaways

• Adbry (tralokinumab-ldrm) 300 mg/2 mL injection autoinjectors (lots 003E24C and 003E24A) are being voluntarily recalled nationwide by LEO Pharma Inc; 11 407 units are affected.
• Class II recall (D-0339-2026) due to lack of sterility assurance after particulate matter identified as wool fiber was found in one unit.
• Adbry is indicated for moderate-to-severe atopic dermatitis in patients aged 12 years and older inadequately controlled on topical therapies.

LEO Pharma Inc is voluntarily recalling select lots of Adbry (tralokinumab-ldrm) injection, 300 mg/2 mL, following a report of particulate matter identified as wool fiber in one unit. The product is packaged as either a single-dose autoinjector labeled “Sample Not for Sale” (NDC 50222-350-91) or as a carton containing 2 single-dose autoinjectors (NDC 50222-350-02). The affected lots are 003E24C and 003E24A, both with an expiration date of April 30, 2027. A total of 11 407 units were distributed nationwide in the US. The product is manufactured by LEO Pharma A/S in Ballerup, Denmark, and distributed in the US by LEO Pharma Inc, Madison, New Jersey.

The recall, numbered D-0339-2026 (event ID 98401), has been classified as a Class II recall by the US Food and Drug Administration (FDA), with the center classification date of February 23, 2026. The recall was voluntarily initiated by the firm on February 10, 2026, and notifications were issued via email to consignees. The recall remains ongoing. A Class II recall indicates that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, with the probability of serious adverse health consequences considered remote.

According to the FDA Enforcement Report, the reason for the recall is lack of assurance of sterility due to the presence of particulate matter in one unit of the lot. Sterility concerns with injectable biologic products are particularly significant given the potential risk of infection or inflammatory response. Adbry is a monoclonal antibody indicated for the treatment of moderate-to-severe atopic dermatitis (eczema) in adult and pediatric patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Reference

FDA. Enforcement Report. February 23, 2026. Accessed February 26, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=218615