OVERLOOKED

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Class IIIOngoing

Chiesi USA, Inc. recalls Revcovi (elapegademase-lvlr) Injection

Recall date · record updated Sep 9, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Chiesi USA, Inc.
Reason
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Hazard
FDA Class III: not likely to cause adverse health consequences (FDA definition).
Who’s affected
MO, TN
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99705…

Products

  1. Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01

    Codes/lots: Lot#: 1221973, Exp 3/24/2027Quantity: 3,002 vialsRecall no. D-0838-2026Class III

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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