FDA recall D-0838-2026

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 for recall

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

Distribution

MO, TN

Key facts

Status

Ongoing

Initiation date

2026-08-19

Report date

2026-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cary, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0838-2026