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Recalls Watch

FDA recall 99972: J&J INNOVATIVE MEDICINE: IMAAVY

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FDARecall 99972Medicines

What to do

The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.

Read the official notice on accessdata.fda.gov (opens in a new tab)

Hazard

Why it was recalled

Presence of particulate matter.
Text from FDA, unedited.

FDA classification: Class II. Use may cause temporary or medically reversible health consequences, or the chance of serious consequences is remote. Status: Ongoing.

Is it yours? Products and codes

Type the lot, batch, date code or model number printed on the product. It is compared here, in your browser, with the codes this notice lists. The code is also added to the page address (?lot=…), so a copied link or result carries it.

General information on recalls from the agency: U.S. Food and Drug Administration (opens in a new tab).

  • 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

    Lot or code
    Lot JNYJ1208; Exp. 10/30/2027
    FDA recall number
    D-0016-2027
    Quantity
    49 vials

Distribution (FDA): OH

About this record

Issued by
U.S. Food and Drug Administration
Firm
J&J INNOVATIVE MEDICINE
Title
Composed by Recalls Watch from fields of the record; FDA records have no title.

If someone was hurt or swallowed something: call 911, or Poison Help at 1-800-222-1222.

About this recall

What is the hazard?

FDA states: “Presence of particulate matter.”

What should I do if I have this product?

The FDA record of this recall has no instruction for consumers. Compare the lot codes on the notice with your product and follow the notice of the firm. The official report is linked on this page.

How do I know if my product is included?

Compare the lot or code printed on your product with the codes FDA lists on this notice, product by product.

How does the code check on this page work?

You type the lot, batch, date code or model number from your package and the page compares it, in your browser, with the codes FDA lists on this notice. It reports a match, a possible match (your code is part of a longer listed code) or no match. It only compares text: a notice that describes products by dates, sizes or “all lots” cannot be compared, so “no match” does not clear a product. The comparison runs in your browser and the page does not send the code anywhere, but the code is added to the page address (?lot=…): a link you copy, share or bookmark carries it, and whoever opens that link requests that address from this site.

When was this recall published?

FDA published recall 99972 on October 14, 2026.

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