Recalls / Class I
Class ID-0005-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Veklury
- Generic name
- Remdesivir
- Active ingredient
- Remdesivir
- Route
- Intravenous
- NDCs
- 61958-2901, 61958-2902
- FDA application
- NDA214787
- Affected lot / code info
- Lot: 47035CFA, Exp. 11/2025
Why it was recalled
Presence of Particulate Matter: Presence of glass particle.
Recalling firm
- Firm
- Gilead Sciences, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 333 Lakeside Dr, N/A, Foster City, California 94404-1147
Distribution
- Quantity
- 105,000 vials
- Distribution pattern
- Nationwide in the U.S.A.
Timeline
- Recall initiated
- 2024-09-19
- FDA classified
- 2024-10-03
- Posted by FDA
- 2024-10-09
- Terminated
- 2025-07-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0005-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.