Class III · Low risk
Revcovi (elapegademase-lvlr)
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
CUROSURF (poractant alfa)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Affected NDC
10122-0510-03
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 |
|---|---|---|---|---|
| Curosurf poractant alfa NDC 10122-0510 |
80 mg/mL | Suspension Endotracheal |
Chiesi USA, Inc. | Rx |
- Recalling firm
- Chiesi USA, Inc.
- NDC code
- 10122-510-03
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0402-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Chiesi USA, Inc.
All 2026 recalls
Class II · Moderate risk
CLEVIPREX (clevidipine injectable emulsion)
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 sterility / contamination recalls from 2026
All sterility / contamination recalls
Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Lack of Assurance of Sterility
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