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IMAAVY Injection, 300 mg /1.62 mL per single-dose vial, For Intravenous Recall 2026

IMAAVYIssued September 23, 2026Updated Reviewed by the Recall Watch editorial team

IMAAVY IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC — recalled per FDA on 9/23/2026. Reason: Presence of particulate matter..

Agency
FDA
Issued
Sep 23, 2026
Brand
IMAAVY
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 September 23, 2026 · Last synced Oct 21, 2026

What's recalled

IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01

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Why it was recalled

Presence of particulate matter.

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 JNYJ1208
Exp. 10/30/2027
Where was it sold
1 state

OH

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

Frequently asked questions

Is the IMAAVY recall still active?

Yes, this recall is currently active as of September 23, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot JNYJ1208, Exp. 10/30/2027. Check the label on your product.

What should I do if I have the recalled IMAAVY?

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