LEO Pharma Inc. Recalls Adbry Injection Due to Potential Wool Fiber Contamination
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LEO Pharma Inc. is recalling 11,407 units of Adbry (tralokinumab-ldrm) injection after wool fiber was found in a unit, compromising the product's sterility.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
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What Happened
LEO Pharma Inc. has initiated a voluntary recall of Adbry (tralokinumab-ldrm) injection, 300 mg/2mL, due to a lack of assurance of sterility. The recall was triggered after laboratory testing identified particulate matter—specifically wool fiber—in one unit from the affected production.
Which Products Are Affected
The recall involves 11,407 units distributed nationwide across the United States. The affected products include:
- Adbry (tralokinumab-ldrm) injection, 300 mg/2mL (1 x Single dose Autoinjector, SAMPLE NOT FOR SALE): NDC 50222-350-91, Lot 003E24C, Expiration Date 04/30/2027.
- Adbry (tralokinumab-ldrm) injection, 300 mg/2mL (2 x Single dose Autoinjectors): NDC 50222-350-02, Lot 003E24A, Expiration Date 04/30/2027.
What You Should Do
Consumers, pharmacists, and healthcare providers should immediately stop using or distributing the affected lots. LEO Pharma Inc. began notifying customers of the issue via e-mail on February 10, 2026. For questions regarding returns or further instructions, contact LEO Pharma Inc. at their Madison, NJ location.
Why This Matters
The presence of foreign particulate matter in an injectable medication represents a significant safety risk. Contamination can compromise the sterility of the drug, potentially leading to serious health complications or infections upon injection.
Source
This recall information is sourced from the FDA. Recall Number: D-0339-2026.
Original source: FDA Official Notice ↗
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