Class III

Drug Recall: 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

Chiesi USA, Inc. · August 19, 2026

Reason for Recall

Failed Stability Specifications: Out of specification stability result for the protein concentration profile.

Distribution

MO, TN

States Affected

MO, TN

Quantity Affected

3,002 vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0838-2026

Status: ongoing

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