Class I · High risk
Cefazolin in Dextrose
Presence of Particulate Matter
Cefazolin for Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was 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
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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).
Affected NDC
0781-3451-96
Compare with the code on your package — it is the most precise check available.
Drug: Cefazolin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cefazolin NDC 00781-3451 |
SODIUM 1 g/1 | Injection, Powder, for Solution Intramuscular|intravenous|parenteral |
Sandoz Inc | Rx |
- Recalling firm
- Sandoz Inc
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jun 27, 2025 · FDA notice with lot numbers
- FDA recall number
- D-0569-2025 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Cefazolin recalls
See all
Class II · Moderate risk
ceFAZolin sodium in Sterile Water for injection
Lack of assurance of sterility.
Class II · Moderate risk
CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR
Lack of sterility assurance
Class II · Moderate risk
Cefazolin
Lack of sterility assurance
Class II · Moderate risk
Cefazolin for injection USP
cGMP deviations: Temperature abuse
Other recalls by Sandoz Inc
All 2025 recalls
Class III · Low risk
Focalin XR
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Cyclophosphamide Injection 500 mg/5 mL
cGMP deviations: Temperature excursion during transportation.
Class II · Moderate risk
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Temperature Abuse
Class I · High risk
Buffered Penicillin G Potassium for Injection
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
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