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Class III · Lower riskActive recall

Revcovi

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot#: 1221973, Exp 3/24/2027
Where it was soldMO, TN
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byChiesi USA, Inc.
Brand nameREVCOVI
Generic nameELAPEGADEMASE-LVLR
Active ingredient(s)ELAPEGADEMASE
Distributed by / forChiesi USA, Inc.
NDC10122-502-01
Show the full FDA record
Full product labelRevcovi (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
Recalling firmChiesi USA, Inc.
DistributionMO, TN
Quantity3,002 vials
Recall initiated2026-08-19
Report date2026-09-09
Recall completed—
Recall numberD-0838-2026
ClassificationClass III
FDA statusOngoing
Origin on fileCary NC United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.