FDA Drug · D-0838-2026

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

Class III · Ongoing

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

Affected lots / codes — check yours against thisLot#: 1221973, Exp 3/24/2027

Recalling firm: Chiesi USA, Inc., Cary, NC
Classification: Class III (unlikely to cause harm)
Status: Ongoing
Quantity: 3,002 vials
Distribution: MO, TN
Recall initiated: August 19, 2026
Classified: September 11, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0838-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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