CLASS II ONGOING Drug recall · Reported 4 Mar 2026 · FDA Enforcement Report
Adbry, (tralokinumab-ldrm) injection, 300 mg recalled by Leo Pharma
LEO Pharma is recalling Adbry, (tralokinumab-ldrm) injection, 300 mg/, Packaged as a) 1 x Single dose, distributed nationwide in the US. The recall was initiated on 10 Feb 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0339-2026
- FDA event ID
- 98401
- Recalling firm
- LEO Pharma, Madison, NJ
- Brand
- Adbry
- Manufacturer
- LEO Pharma Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Feb 2026
- FDA classified
- 23 Feb 2026
- Reported
- 4 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Feb 2026 | Recall initiated by company | |
| 23 Feb 2026 | Classified by FDA | +13 days |
| 4 Mar 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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,
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it 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.
Which lots are affected?
Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LEO Pharma
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|---|---|---|---|---|---|
| Drug | CLASS II | Calcipotriene Cream recalled by Leo PharmaCalcipotriene | LEO Pharma | Labeling Errors | Nationwide |
| Drug | CLASS III | Taclonex (calcipotriene and betamethasone dipropionate) recalledTaclonex | LEO Pharma | Packaging Defects | Nationwide |