Revcovi Injection
FDA Recall NDC 10122-502
Latest: Class III · Status: Ongoing · Initiated Aug 19, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Revcovi (NDC 10122-502). A significant event, classified as Class III, was initiated on Aug 19, 2026 by Chiesi Usa, Inc.. The reported reason for this action was: "Failed Stability Specifications: Out of specification stability result for the protein concentration profile."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Aug 19, 2026
Sep 09, 2026
3,002 vials
Recall Profile & Regulatory Data
Event ID
99705
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Chiesi USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
MO, TN
Product Description
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
Batch or Lot Expiration Information
Lot# : 1221973, Exp 3/24/2027
Affected Packages Involved in this Recall
10122-502-01Revcovi
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
