Class II · Moderate risk
CLEVIPREX (clevidipine injectable emulsion)
Lack of Assurance of Sterility
Revcovi (elapegademase-lvlr)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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
Affected NDC
10122-0502-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Revcovi elapegademase-lvlr NDC 10122-0502 |
ELAPEGADEMASE 1.6 mg/mL | Injection Intramuscular |
Chiesi USA, Inc. | Rx |
- Recalling firm
- Chiesi USA, Inc.
- NDC code
- 10122-502-01
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0838-2026 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other recalls by Chiesi USA, Inc.
All 2026 recalls
Class II · Moderate risk
CUROSURF (poractant alfa)
Lack of Assurance of Sterility
Class II · Moderate risk
Zileuton Extended-Release Tablets
Failed Dissolution Specifications: Out of specification result for dissolution.
Class II · Moderate risk
ZYFLO CR (zileuton)
Failed Dissolution Specifications: Out of specification result for dissolution.
Other stability / shelf life recalls from 2026
All stability / shelf life recalls
Unclassified
Nystatin Cream
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
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