August 2026 FDA Recall Revcovi by Chiesi Usa, Inc.
D-0838-2026 - Failed Stability Specifications

This Class III drug recall was voluntarily initiated by Chiesi Usa, Inc. on August 19, 2026 for the product Revcovi. The FDA reported the reason for recall as failed stability specifications. The product was distributed in MO, TN and the recall is currently ongoing.

Recall Number: D-0838-2026

Reason for Recall
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Initiated
08-19-2026
Reported
09-09-2026
Quantity
3,002 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99705
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Chiesi USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MO, TN
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : 1221973, Exp 3/24/2027

Affected Packages Involved in this Recall

10122-502-01 Revcovi