Sandoz Inc: Drug Recall
Recall #D-0569-2025 · 06/27/2025
Class I: Dangerous
Recall Details
- Recall Number
- D-0569-2025
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Sandoz Inc
- Status
- Ongoing
- Date Initiated
- 06/27/2025
- Location
- Princeton, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 208,300 vials
Reason for Recall
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Product Description
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
Distribution Pattern
Nationwide in the USA
Other Recalls by Sandoz Inc
- Class II: Risk 09/05/2025
- Class II: Risk 08/13/2025
- Class I: Dangerous 06/27/2025
- Class II: Risk 03/21/2022
- Class I: Dangerous 11/17/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.