FDA Recall D-0339-2026

LEO PHARMA INC · Madison, NJ

Class II Ongoing 93 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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,

Lot / code: Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.

Quantity: 11,407 units

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.

Recall record

Recall number: D-0339-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the USA
Recall initiated: 2026-02-10
Classified by FDA Center: 2026-02-23
FDA published: 2026-03-04
Recalling firm: LEO PHARMA INC
Firm location: Madison, NJ

Drug identification

Brand name(s): ADBRY
Generic name(s): TRALOKINUMAB-LDRM
Manufacturer(s): LEO Pharma Inc.
NDC(s): 50222-346, 50222-350
Route(s): SUBCUTANEOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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