Notice names this product. Chiesi USA’s Revcovi (elapegademase-lvlr) Injection is named in FDA Class III recall D-0838-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Failed Stability Specifications: Out of specification stability result for the protein concentration profile. Identifying details: Lot#: 1221973, Exp 3/24/2027. Units affected: 3,002 vials. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Company / brand: Chiesi USA recalls
Affected product: Revcovi (elapegademase-lvlr) Injection recall status
Official ID D-0838-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.