IMAAVY Injection Recalled Due to the Presence of Particulate Matter

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for IMAAVY (nipocalimab-aahu) injection, 185 mg/mL. The affected batch has been identified as Lot JNYJ1208 (expires October 2027), containing 49 vials.
• The recall was initiated by J&J Innovative Medicine due to the presence of particulate matter, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Nipocalimab-aahu is used to treat generalized myasthenia gravis (gMG).

The FDA has issued a Class II recall for IMAAVY (nipocalimab-aahu) injection, 185 mg/mL, affecting 49 vials. This product is manufactured by Janssen Biotech, Inc and is being recalled by J&J Innovative Medicine based in Malvern, Pennsylvania. The recall was initiated on September 23, 2026, and received a Class II classification on October 8, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated after the firm discovered particulate matter in the product. This issue affects Lot JNYJ1208, which will expire in October 2027. J&J Innovative Medicine sent out a public notice via letter; no press release was issued for this recall.

Nipocalimab-aahu is used to treat gMG. Pharmacists should identify and quarantine Lot JNYJ1208, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. October 14, 2026. Accessed October 14, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=223020