Is this recall still active?

The FDA lists the recall as ongoing. The recall is still in progress.

Checked Oct 26, 2026

Class IIDrug recallOngoing

IMAAVY (nipocalimab-aahu) Injection recall

Recalled by J&J INNOVATIVE MEDICINE of Malvern, PA · FDA report 10/14/2026

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class II; Moderate
Status: Ongoing
Recall started: 09/23/2026
Distribution: See below

Reason for recall

Presence of particulate matter.

Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

Product: 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 and code info: Lot JNYJ1208; Exp. 10/30/2027
Quantity: 49 vials
Brand names: IMAAVY
Recall number: D-0016-2027
Event ID: 99972
Initiated by: Voluntary: Firm initiated

Where it was distributed

Recall timeline

09/23/2026Firm started the recall
10/08/2026FDA classified it as Class II
10/14/2026Published in the FDA enforcement report

Frequently asked questions

Why was IMAAVY (nipocalimab-aahu) Injection recalled?: Presence of particulate matter.
What does Class II mean?: Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Is this recall still active?: The FDA lists the recall as ongoing. The recall is still in progress.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 10/14/2026 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class II
Status: Ongoing
Type: Drug
Reported: 10/14/2026

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

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About this data

Recalls: Recall information comes from NHTSA, FDA, USDA, CPSC and other agencies. A product, vehicle or lot may be affected even if it is not listed here, and listings may be delayed. Check the official recall notice and contact the manufacturer or dealer to confirm whether your item is included.

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