Quality & complianceOfficial

FDA classifies IMAAVY (nipocalimab-aahu) injection recall as Class II over particulate matter

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

Johnson & Johnson Innovative Medicine's IMAAVY injection is subject to an ongoing recall, numbered D-0016-2027, after particulate matter was identified, with distribution recorded in Ohio.

The US Food and Drug Administration has listed a Class II recall of IMAAVY (nipocalimab-aahu) injection, marketed by J&J Innovative Medicine, in its enforcement report dated 14 October 2026.

The recall is recorded under number D-0016-2027. The stated reason is the presence of particulate matter. The status is shown as ongoing, meaning the recall action has not yet been closed.

The entry gives Ohio as the distribution area. The material available does not provide lot numbers, quantities, dates of manufacture or details on how the particulate matter was found, nor does it say whether any adverse events have been reported.

For context, FDA assigns Class II to recalls where use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Quality teams handling injectable biologics should note particulate matter as a recurring recall reason and check visual inspection and container-closure controls.
  • Supply chain and distribution teams with product in Ohio should consult the full FDA enforcement entry for lot and code details, which are not covered here.
  • Pharmacovigilance teams may wish to review complaint and adverse event intake for any reports linked to visible particles in IMAAVY.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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