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.
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,
Lot numbers, UPCs & expiration codes
Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0339-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 10, 2026
- FDA report date
- Mar 4, 2026
- Quantity
- 11,407 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LEO PHARMA INC
Original FDA data
Every field from FDA enforcement report D-0339-2026, exactly as published.
Show all FDA fields
- City
- Madison
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98401
- Address
- 7 Giralda Farms
- Code information
- Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
- Postal code
- 07940-1051
- Report date
- Mar 4, 2026
- Product type
- Drugs
- Recall number
- D-0339-2026
- Classification
- Class II
- Recalling firm
- LEO PHARMA INC
- Product 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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,
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 10, 2026
- Initial firm notification
- Center classification date
- Feb 23, 2026