Class IIIDrug
Revcovi recall
Summary
Chiesi USA, Inc. is recalling Revcovi (elapegademase-lvlr) Injection (drug). According to the FDA report, the reason is: Failed Stability Specifications: Out of specification stability result for the protein concentration profile. The FDA rated this a Class III: the product is unlikely to cause health problems but violates fda rules (e.g. labeling). Recall status: Ongoing.
Details from the FDA report
- 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.
- Lot / code info
- Lot#: 1221973, Exp 3/24/2027
- Quantity
- 3,002 vials
- Distribution
- MO, TN
- Recalling company
- Chiesi USA, Inc., Cary, NC United States
- Recall started
- August 19, 2026
- FDA report date
- September 9, 2026
- Classification
- Class III: The product is unlikely to cause health problems but violates FDA rules (e.g. labeling).
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0838-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Chiesi USA, Inc.) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.