Revcovi (elapegademase-lvlr) Injection recall
FDA recall D-0838-2026 · initiated Aug 19, 2026
Chiesi USA, Inc. recalled Revcovi (elapegademase-lvlr) Injection in Aug 2026 — an FDA Class III recall (D-0838-2026) because Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3,002 vials
Details
- Product
- 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
- Recalling company
- Chiesi
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- MO, TN
- Initiated
- Aug 19, 2026
- FDA report date
- Sep 9, 2026
Frequently asked
- Was Revcovi (elapegademase-lvlr) Injection recalled?
- Chiesi USA, Inc. recalled Revcovi (elapegademase-lvlr) Injection in Aug 2026 — an FDA Class III recall (D-0838-2026) because Failed Stability Specifications: Out of specification stability result for the protein concentration profile. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Revcovi (elapegademase-lvlr) Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0838-2026 was: Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
- Is a recalled Revcovi (elapegademase-lvlr) Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Revcovi (elapegademase-lvlr) Injection are affected?
- Distributed: MO, TN. The recall covers these lots — Lot#: 1221973, Exp 3/24/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0838-2026.