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

FDA recall notice · announced September 9, 2026 · Chiesi

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: MO, TN
Lot/code information: Lot#: 1221973, Exp 3/24/2027
Quantity: 3,002 vials
Status: Ongoing
Products in this recall event:
- 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 (D-0838-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.