September 2024 FDA Recall Veklury by Gilead Sciences, Inc.
D-0005-2025 - Presence of Particulate Matter
This Class I drug recall was voluntarily initiated by Gilead Sciences, Inc. on September 19, 2024 for the product Veklury. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0005-2025
Presence of Particulate Matter: Presence of glass particle.
09-19-2024
10-09-2024
105,000 vials
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Gilead Sciences, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S.A.
07-29-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2
Batch or Lot Expiration Information
Lot# Lot: 47035CFA, Exp. 11/2025
