Recall: D-0838-2026

Class III - Minor Violations

Class IIIClassification

2026-08-19Initiated

OngoingStatus

Chiesi USA, Inc.Firm

Product

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

Reason

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

Distribution

MO, TN

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.