IMAAVY (nipocalimab-aahu) Recall D-0016-2027 for Particulate Matter

J&J INNOVATIVE MEDICINE recalled 49 vials of IMAAVY (nipocalimab-aahu) Injection, 300 mg per 1.62 mL (185 mg/mL), a single-dose vial for intravenous infusion after dilution, because of the presence of particulate matter. The firm initiated the recall voluntarily on September 23, 2026. The US Food and Drug Administration (FDA) assigned recall number D-0016-2027 and classified it Class II on October 8, 2026.

At a glance

• J&J INNOVATIVE MEDICINE recalled 49 vials of IMAAVY (nipocalimab-aahu) Injection, NDC 57894-800-01, lot JNYJ1208, with an expiration date of October 30, 2027.
• The FDA listed the reason for the recall as “Presence of particulate matter.”
• The recall is designated Voluntary: Firm initiated, and the firm’s initial notification method was a letter.
• The FDA classified the action as Class II and reported it on October 14, 2026.
• The distribution pattern recorded in the FDA enforcement record is OH, meaning Ohio.

What the FDA enforcement record shows

The FDA enforcement record identifies the recalling firm as J&J INNOVATIVE MEDICINE, at 200 Great Valley Pkwy, Malvern, PA 19355-1307. The product description names Janssen Biotech, Inc., Horsham, PA 19044, as the manufacturer. The same record lists Janssen Biotech, Inc. as the manufacturer name in the openFDA product fields, and it lists the application number as BLA761430, a Biologics License Application.

IMAAVY is identified as a human prescription drug given by the intravenous route, with the active substance nipocalimab. The FDA record lists four product NDCs (57894-800, 57894-801, 2712699 and related codes are listed as RxCUI identifiers) and two package NDCs: 57894-800-01 and 57894-801-01. The recalled lot is JNYJ1208.

The quantity in the record is narrow: 49 vials. The distribution pattern covers Ohio only. The record describes the recall status as Ongoing, meaning the FDA has not listed it as terminated. On the FDA Drug Recalls page, the agency explains that a recall is a voluntary action by a company to remove a defective drug from the market or warn about a potential risk. That page also explains that recalls not indicated as terminated are either ongoing or completed, and that a terminated recall is one where the FDA has determined all reasonable efforts were made to remove or correct the violative product.

What is established vs. what is alleged

Established: the FDA published an enforcement record for recall number D-0016-2027, dated October 14, 2026, covering 49 vials of IMAAVY lot JNYJ1208. Established: the record states the reason for the recall as particulate matter, and the recall is firm initiated. Established: the FDA assigned a Class II classification on October 8, 2026.

Not established by these documents: what the particles were made of, how they entered the product, or whether any vial reached a patient. The FDA record does not identify the particulate material, unlike some other recall entries on the same Drug Recalls page that name cellulose, stopper material or iron oxide. There is no allegation of injury in this record, and no court has made any finding about this product. A Class II designation is an FDA classification of the recall, not a judicial determination and not a finding that harm occurred.

Where the recall stands procedurally

There is no federal court consolidation tied to this recall in the source documents. No multidistrict litigation (MDL, a procedure that groups similar federal cases before one judge) is identified, and the Judicial Panel on Multidistrict Litigation (JPML, the body that decides whether to consolidate) is not mentioned. The source documents contain no complaint, docket number, bellwether trial (a test case chosen from a group to gauge how others might resolve) or settlement.

The regulatory posture is straightforward. The firm notified recipients by letter and initiated the recall on September 23, 2026. The FDA classified it on October 8, 2026, and reported it on October 14, 2026. The status field reads Ongoing as of the FDA data update on October 21, 2026.

Readers comparing this action with other pharmaceutical recall programs can review the site’s coverage of sartan recalls and the metoclopramide tablet recall. For context on how product liability claims develop after a safety event, see the Oxbryta withdrawal litigation overview.

Key dates

• September 23, 2026: J&J INNOVATIVE MEDICINE initiated the voluntary recall of IMAAVY lot JNYJ1208.
• October 8, 2026: the FDA assigned the Center classification date for recall D-0016-2027.
• October 14, 2026: the FDA reported the recall in its enforcement data and on the Drug Recalls page.
• October 21, 2026: the FDA enforcement dataset was last updated, listing the recall as Ongoing.
• October 30, 2027: the expiration date recorded for lot JNYJ1208.

What this does not establish

The documents do not show that any patient received a vial from lot JNYJ1208, and they do not describe any adverse event. They do not state the identity or source of the particulate matter. They do not show a recall termination, which under the FDA’s own description would require a determination that all reasonable efforts were made and proper disposition completed. They do not contain a recall announcement press release specific to IMAAVY, a Drug Safety Communication about IMAAVY, a field correction notice, or any statement from Janssen Biotech, Inc. beyond the product description in the enforcement record.

The documents also do not establish any legal claim, any injury, or any compensation. A recall record documents a firm’s removal action and the FDA’s classification; it is not a finding of fault.

Frequently asked questions

What is the IMAAVY nipocalimab-aahu recall D-0016-2027?

Recall D-0016-2027 is the FDA’s record of a voluntary recall by J&J INNOVATIVE MEDICINE of 49 vials of IMAAVY (nipocalimab-aahu) Injection, 300 mg per 1.62 mL, for the presence of particulate matter. The firm initiated the recall on September 23, 2026, and the FDA classified it Class II on October 8, 2026. The record lists lot JNYJ1208 and an expiration date of October 30, 2027.

Which lots and how many vials did the IMAAVY recall cover?

The FDA enforcement record lists lot JNYJ1208 with an expiration date of October 30, 2027, and a total quantity of 49 vials. The product is identified as NDC 57894-800-01, a single-dose vial for intravenous infusion after dilution. The distribution pattern recorded for the recall is Ohio.

What does a Class II recall classification mean?

The FDA classified recall D-0016-2027 as Class II on October 8, 2026, which is the agency’s hazard designation for the action. The FDA Drug Recalls page states that recalls not indicated as terminated are either ongoing or completed, and that a terminated recall requires a determination that all reasonable efforts were made and proper disposition completed. The record for this recall shows the status as Ongoing, not terminated.

Has the IMAAVY recall led to any lawsuit or MDL?

The source documents identify no lawsuit, docket number or MDL connected to recall D-0016-2027, and they do not mention the JPML. The records available describe a firm-initiated recall and FDA classification only. Any future litigation would appear in court records that these documents do not include.

Where can a reader find the official IMAAVY recall record?

The official record is the FDA enforcement entry for recall number D-0016-2027, accessible through openFDA and summarized on the FDA Drug Recalls page. That page allows filtering by terminated recall status, and it explains the difference between ongoing, completed and terminated actions. Readers with questions about a specific vial should consult a pharmacist or prescriber rather than relying on a summary article.

Sources

1. U.S. Food and Drug Administration (openFDA): “Drug Enforcement Report, Recall Number D-0016-2027” (link, accessed 2026-10-30)
2. U.S. Food and Drug Administration: “Drug Recalls” (link, accessed 2026-10-30)
3. U.S. Food and Drug Administration: “Drug Safety Communications” (link, accessed 2026-10-30)
4. U.S. Food and Drug Administration: “Drugs@FDA Data Files” (link, accessed 2026-10-30)
5. U.S. Food and Drug Administration: “What’s New: Drugs RSS Feed” (link, accessed 2026-10-30)
6. U.S. Food and Drug Administration: “Drug Safety and Availability” (link, accessed 2026-10-30)