Leo Pharma recalls
FDA enforcement reports naming LEO PHARMA INC as the recalling firm.
- Recall reports
- 3
- Class I (serious)
- 0
- Most recent report
- Mar 4, 2026
- Mar 4, 2026Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoin…Drug · LEO PHARMA INCLack 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.Class II
- Mar 15, 2017Calcipotriene Cream 0Drug · LEO PHARMA INCIncorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into…Class II
- Feb 22, 2017Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0Drug · LEO PHARMA INCLabeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.Class III