drugs MODERATE Updated 2026-10-14

J&J INNOVATIVE MEDICINE recalls IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg

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Recalled 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

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Hazard / Issue

Presence of particulate matter.

Issued by

FDA

Affected States: OH
Lot/Code Info: Lot JNYJ1208; Exp. 10/30/2027

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.

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