REVCOVI
Recalling Firm / Manufacturer: Chiesi USA, Inc.
(Cary, NC, United States)
FDA Recall Number: D-0838-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
REVCOVI
Generic Name
ELAPEGADEMASE-LVLR
Active Substance(s)
Elapegademase
Administration Route
Intramuscular
National Drug Code (NDC)
10122-502
Total Quantity Recalled
3,002 vials
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
September 09, 2026
Firm Initiation Date
August 19, 2026
FDA Classification Date
Sep 11, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot#: 1221973, Exp 3/24/2027
Distribution Information
Geographic scope of affected shipments
MO, TN
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0838-2026
Questo Retrieval Date: September 23, 2026 00:00 1790121612UTCC