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Adbry, injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector Recall 2026

ADBRYIssued February 10, 2026Updated Reviewed by the Recall Watch editorial team

ADBRY 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, Manu — recalled per FDA on 2/10/2026. Reason: 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..

Agency
FDA
Issued
Feb 10, 2026
Brand
ADBRY
Distribution
1 states
Lots affected
4
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued February 10, 2026 · Last synced Nov 1, 2026

What's recalled

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,

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Why it was 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.

Affected products & lot numbers
4 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot: a) 003E24C
Exp 04/30/2027
b) 003E24A
Exp 04/30/2027.
Where was it sold
1 state

Nationwide in the USA

nationwide
Official noticefda.gov
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the ADBRY recall still active?

Yes, this recall is currently active as of February 10, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot: a) 003E24C, Exp 04/30/2027, b) 003E24A, Exp 04/30/2027.. Check the label on your product.

What should I do if I have the recalled ADBRY?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.