FDA-Drug2026-09-09Class IIICHEMICAL
Chiesi Revcovi injection recalled for failed stability specifications
What this means
Chiesi USA, Inc. is recalling Revcovi (elapegademase-lvlr) Injection due to out-of-specification stability results in the protein concentration profile. The affected lot was distributed to Missouri and Tennessee. No injuries have been reported.
- If you have a vial from lot #1221973 (expiration 3/24/2027), contact your healthcare provider or pharmacist immediately.
- Do not use the recalled medication without consulting your healthcare provider.
- Return the medication to your pharmacy for proper handling.
The agency's original wording
Hazard
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Intended for
All ages (0 months and older)
Illnesses reported
None reported
Sold states
MO, TN
Affected count
3,002 vials
Manufactured in
175 Regency Woods Pl Ste 600, N/A, Cary, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0838-2026More Chiesi recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.