Revcovi recall (Chiesi USA, Inc.)
DrugClass IIIOngoing
Summary: Chiesi USA, Inc. is recalling 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.
What is being recalled
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
Why
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
MO, TN (states named: Missouri, Tennessee)
How to tell if yours is affected
Lot#: 1221973, Exp 3/24/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0838-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | August 19, 2026 |
| Reported | September 9, 2026 |
| Company | Chiesi USA, Inc. |
| Company location | Cary, NC, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3,002 vials |
More recalls from Chiesi USA, Inc. · all drug recalls · recalls from August 2026