Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only,
Summary
The FDA issued a Class III for Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Via by Chiesi USA, Inc.. Reason: Failed Stability Specifications: Out of specification stability result for the protein concentration profile..
Details
Source
Drug Recall
External ID
D-0838-2026
Action Date
2026-09-09
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot#: 1221973, Exp 3/24/2027
Quantity Affected: 3,002 vials
Reason for Recall
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Distribution
MO, TN
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-19
Company
Cary, NC
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 53 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Chiesi USA, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Chiesi USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Chiesi USA, Inc. have FDA actions?
Chiesi USA, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0838-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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