ADBRY Injection Drug Recall for Particulate Contamination
LEO Pharma is recalling its ADBRY injection drug due to particulate matter (wool fiber) found in one unit, which may affect sterility. The recall covers 11,407 units distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for sterility failure with particulate matter in injectable drug; no reported injuries but represents risk-of-harm product where injury has not yet been reported per rubric criteria.
Plain-English summary
ADBRY (tralokinumab-ldrm) injection, 300 mg/2mL, is being recalled by LEO Pharma Inc. due to a lack of assurance of sterility. Laboratory testing identified wool fiber as particulate matter in one unit from the affected lots. The affected products are packaged as single-dose autoinjectors (lot 003E24C) and two-pack autoinjectors (lot 003E24A), both with expiration date 04/30/2027. The recall affects 11,407 units distributed nationwide in the USA.
No illnesses or injuries have been reported in connection with this recall. Healthcare providers and patients should return affected products to LEO Pharma for a full refund. Patients should contact their healthcare provider to discuss alternative treatment options.
The recalled product
- Product
- ADBRY (TRALOKINUMAB-LDRM)
- Brand
- ADBRY
- Manufacturer
- LEO PHARMA INC
- Category
- Drug — Injectable drug
- Affected units
- 11,407
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: a) 003E24C
- Exp 04/30/2027
- b) 003E24A
- Exp 04/30/2027.
Distribution
Distributed nationwide across the United States.
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