Revcovi — Class III drug recall D-0838-2026
Ongoing recall by Chiesi USA, Inc., reported 2026-09-09, distributed in MO, TN. Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
| Recall number | D-0838-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Chiesi USA, Inc., Cary, NC, United States |
| Recall initiated | 2026-08-19 |
| Classified | 2026-09-11 |
| Reported by FDA | 2026-09-09 |
| Distributed | MO, TN |
| Quantity | 3,002 vials |
| Reason classes | specification failure |
| NDC | 10122-0502, 10122-0502-01 |
| Lot numbers | 1221973 |
| Expiration dates | 2027-03-24 |
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 for recall
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0838-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.