CLASS I ONGOING Drug recall · Reported 9 Jul 2025 · FDA Enforcement Report
Cefazolin for Injection, USP per vial, Sterile recalled by Sandoz
Sandoz is recalling Cefazolin for Injection, USP per vial, Sterile, For Intramuscular or Intravenous Use, distributed nationwide in the US. The recall was initiated on 27 Jun 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0569-2025
- FDA event ID
- 97140
- Recalling firm
- Sandoz, Princeton, NJ
- Brand
- Cefazolin
- Manufacturer
- Sandoz Inc
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 27 Jun 2025
- FDA classified
- 6 Aug 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Jun 2025 | Recall initiated by company | |
| 9 Jul 2025 | Published in enforcement report | +12 days |
| 6 Aug 2025 | Classified by FDA | +28 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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).
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot # PG4360, PG4362, Exp. 11/30/2027
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97140| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium | Sandoz | Labeling Errors | Nationwide |
More recalls from Sandoz
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS I | Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium | Sandoz | Labeling Errors | Nationwide |
| Drug | CLASS II | Orphenadrine Citrate Extended-Release Tablets, USP 100 mg recalledOrphenadrine Citrate | Sandoz | Nitrosamine Impurity | Nationwide |
Other Cefazolin recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cefazolin in Dextrose, Injection recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | ceFAZolin sodium in Sterile Water for injection recalled | Wells Pharma of Houston | Sterility | PA |
| Drug | CLASS II | Cefazolin 5mg/mL/Heparin/ml Syr, antibiotic recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Cefazolin for injection USP, and Dextrose Injection recalledCefazolin Sodium | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cefazolin for injection USP, and Dextrose Injection recalledCefazolin Sodium | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |