FDA Drugs recall ·
Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL)… recall
- Recall number
- D-0838-2026
- Date
- (initiated August 19, 2026)
- Company / brand
- Chiesi USA, Inc.
175 Regency Woods Pl Ste 600, Cary, NC, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 3,002 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: 1221973, Exp 3/24/2027
Distribution
MO, TN
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0838-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.