Why it was recalled
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: 1221973, Exp 3/24/2027
Where it was sold
MO, TN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0838-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Aug 19, 2026
- FDA report date
- Sep 9, 2026
- Quantity
- 3,002 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Chiesi USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0838-2026, exactly as published.
Show all FDA fields
- City
- Cary
- State
- NC
- Status
- Ongoing
- Country
- United States
- Event ID
- 99705
- Address
- 175 Regency Woods Pl Ste 600
- Code information
- Lot#: 1221973, Exp 3/24/2027
- Postal code
- 27518-6007
- Report date
- Sep 9, 2026
- Product type
- Drugs
- Recall number
- D-0838-2026
- Classification
- Class III
- Recalling firm
- Chiesi USA, Inc.
- Product quantity
- 3,002 vials
- Reason for recall
- Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- MO, TN
- Recall initiation date
- Aug 19, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 11, 2026