D-0339-2026 Class II Ongoing
FDA drug recall D-0339-2026 was initiated by LEO PHARMA INC on Feb 10, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 11,407 units.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 4, 2026
- Initiation Date
- Feb 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,407 units
Product description
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 pattern
Nationwide in the USA
Code information
Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0339-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026