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FDA · DrugsClass I

Sandoz Inc drug recall: Cefazolin for Injection

Labeling errors

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Drugs
Classification
Class I
Status
Ongoing
Event ID
97140
Recall initiated
Jun 27, 2025
Classified by FDA
Aug 6, 2025
Posted in Enforcement Report
Jul 9, 2025
Recalling firm
Sandoz Inc
Firm location
Princeton, NJ, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Press Release
Products in this event
2

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

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

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

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Jun 27, 2025. FDA classified it 40 days later, on Aug 6, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: Nationwide in the USA Sandoz Inc has 47 recalls in our records.

Recalled products (2)

  • D-0569-2025 Class I Ongoing

    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).

    Codes / lots: Lot # PG4360, PG4362, Exp. 11/30/2027

    Quantity: 208,300 vials

  • D-0570-2025 Class I Ongoing

    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.

    Codes / lots: Lot # PG4360, PG4362, Exp. 11/30/2027

    Quantity: unknown

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
Official notice
FDA Enforcement Report, event 97140
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.