FDA Drugs recall ·
Cefazolin for Injection, USP, 1 gram per vial, Sterile… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0569-2025
- Date
- (initiated June 27, 2025)
- Company / brand
- Sandoz Inc
100 College Rd W, Princeton, NJ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 208,300 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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).
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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # PG4360, PG4362, Exp. 11/30/2027
Distribution
Nationwide in the USA
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0569-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.