FDA Drug recall D-0838-2026
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,…
- FDA Drug
- Class III
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class III recall of 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,… by Chiesi Usa, citing failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0838-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-08-19 |
| Published | 2026-09-09 |
| Last updated | 2026-09-23 05:30 UTC |
| Company | Chiesi Usa |
| Distribution | MO, TN |
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.
Identifiers
| ndc | 10122-502-01 |
|---|---|
| code_info | Lot#: 1221973, Exp 3/24/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-23 05:30 UTC. Current status: ongoing.
Other recalls by Chiesi Usa
- CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Car…
FDA Drug · Class II · 2026-07-22 · Chiesi Usa - CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03
FDA Drug · Class II · 2026-04-01 · Chiesi Usa - ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 1012…
FDA Drug · Class II · 2019-06-19 · Chiesi Usa - Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA
FDA Drug · Class II · 2019-06-19 · Chiesi Usa
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0838-2026%22
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