Chiesi USA, Inc. recalls Revcovi
- Recalling company
- Chiesi USA, Inc.
- 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
- Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Aug 19, 2026
- Reported
- Sep 9, 2026
- Distribution
- MO, TN
- Status
- Ongoing
- Quantity
- 3,002 vials
- Lot / codes
- Lot#: 1221973, Exp 3/24/2027
- Company location
- Cary, NC
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0838-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0838-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.