Recall archive / FDA drug enforcement
Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Onl... — FDA record D-0838-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 19, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class III
- Recalling firm
- Chiesi USA, Inc.
- Quantity
- 3,002 vials
- Agency-reported status
- Ongoing
- Source record identifier
- D-0838-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot#: 1221973, Exp 3/24/2027 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
MO, TN
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 9, 2026
- Recall initiation date
- Aug 19, 2026
- Center classification date
- Sep 11, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.