FDA recall, , Low risk
Revcovi (Elapegademase-Lvlr) Injection
Revcovi injection failed stability specifications for protein concentration profile.
Summary by Recall Canary from the FDA notice
What happened
Chiesi USA, Inc., of Cary, North Carolina, recalled Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, because of an out of specification stability result for the protein concentration profile. The recall began August 19, 2026, and the FDA added it to its Enforcement Report on August 28, 2026. The product was distributed in Missouri and Tennessee.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Revcovi (elapegademase-lvlr) Injection
- NDC
- 10122-502-01
- Lot code
- 1221973
Recall details
- Company began the recall
- Company
- Chiesi USA, Inc.Cary, North Carolina
- Hazard
- Quality testing problem
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99705
- Recall number
- D-0838-2026
- Quantity recalled
- 3,002 vials
All recalls from Chiesi USA, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
