Multi event Drug Recall Enforcement Report Class I voluntary initiated by Sandoz Inc, originally initiated on 06-27-2025 for the product 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). The product was recalled due to 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. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0569-2025 | 06-27-2025 | 07-09-2025 | Class I | 208,300 vials | 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). | 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 | Ongoing |
| D-0570-2025 | 06-27-2025 | 07-09-2025 | Class I | unknown | Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94. | Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0781-3450 | Cefazolin | Cefazolin | Injection, Powder, For Solution | Intramuscular; Intravenous; Parenteral | Sandoz Inc | Human Prescription Drug |
| 0781-3451 | Cefazolin | Cefazolin | Injection, Powder, For Solution | Intramuscular; Intravenous; Parenteral | Sandoz Inc | Human Prescription Drug |
| 0781-6135 | Penicillin G Potassium | Penicillin G Potassium | Injection, Powder, For Solution | Intramuscular; Intravenous | Sandoz Inc | Human Prescription Drug |
| 0781-6136 | Penicillin G Potassium | Penicillin G Potassium | Injection, Powder, For Solution | Intramuscular; Intravenous | Sandoz Inc | Human Prescription Drug |
