CLASS III ONGOING Drug recall · Reported 9 Sep 2026 · FDA Enforcement Report
Revcovi (elapegademase-lvlr) Injection, 2.4mg/ (1.6 mg/mL) recalled
Chiesi USA is recalling Revcovi (elapegademase-lvlr) Injection, 2.4mg/ (1.6 mg/mL), Single-Dose Vial, distributed in Missouri, Tennessee. The recall was initiated on 19 Aug 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0838-2026
- FDA event ID
- 99705
- Recalling firm
- Chiesi USA, Cary, NC
- Brand
- Revcovi
- Manufacturer
- Chiesi USA, Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 19 Aug 2026
- FDA classified
- 11 Sep 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Aug 2026 | Recall initiated by company | |
| 9 Sep 2026 | Published in enforcement report | +21 days |
| 11 Sep 2026 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
MO, TN
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Which lots are affected?
Lot#: 1221973, Exp 3/24/2027
Where was it sold?
MO, TN
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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