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IMULDOSA, Injection, 130 mg/26 mL , Rx only, Single dose vial Recall 2026

IMULDOSAIssued June 10, 2026Updated Reviewed by the Recall Watch editorial team

IMULDOSA IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactu — recalled per FDA on 6/10/2026. Reason: Lack of assurance of Sterility:.

Agency
FDA
Issued
Jun 10, 2026
Brand
IMULDOSA
Distribution
1 states
Lots affected
2
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 June 10, 2026 · Last synced Nov 1, 2026

What's recalled

IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.

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Why it was recalled

Lack of assurance of Sterility:

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

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

Lot Number
Lot # 004L24A
Exp Date: 02/19/2027.
Where was it sold
1 state

US Nationwide.

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

Frequently asked questions

Is the IMULDOSA recall still active?

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

What lot numbers are affected?

Affected lot numbers: Lot # 004L24A, Exp Date: 02/19/2027.. Check the label on your product.

What should I do if I have the recalled IMULDOSA?

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