Class II
Ongoing
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,
This recall is currently active, issued March 4, 2026. It was issued by Leo Pharma Inc.
- Company
- Leo Pharma Inc
- Recall Initiated
- February 10, 2026
- Posted
- March 4, 2026
- Recall Number
- D-0339-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,407 units
- Firm Location
- Madison, NJ, United States
- Official Source
- View on FDA website ↗
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
Nationwide in the USA
Lot / Code Info
Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
More recalls by Leo Pharma Inc
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron St...
Fresenius Kabi Compounding, Llc
· Feb 18, 2026