RecallReported October 14, 2026
Class II recall by J&J INNOVATIVE MEDICINE
IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Man…
FDA's enforcement report of October 14, 2026 lists a Class II recall by J&J INNOVATIVE MEDICINE of Malvern, PA. Product: IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Man…. Status: Ongoing.
On the record
- Recalling firm
- J&J INNOVATIVE MEDICINE
- Location
- Malvern, PA
- Classification
- Class II
- Status
- Ongoing
- Recall number
- D-0016-2027
- Product type
- Drugs
- Brand names
- IMAAVY
- Generic names
- NIPOCALIMAB-AAHU
- Recall initiated
- 2026-09-23
- Reported by FDA
- 2026-10-14
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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