LEO Pharma Inc. Recalls Adbry Injection Due to Potential Wool Fiber Contamination

Source: FDA · United States

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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 March 10, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.