FDA Recall D-0569-2025

Sandoz Inc · Princeton, NJ

Class I — life-threatening Ongoing 321 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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).

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

Quantity: 208,300 vials

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

Recall record

Recall number: D-0569-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the USA
Recall initiated: 2025-06-27
Classified by FDA Center: 2025-08-06
FDA published: 2025-07-09
Recalling firm: Sandoz Inc
Firm location: Princeton, NJ

Drug identification

Brand name(s): CEFAZOLIN
Generic name(s): CEFAZOLIN
Manufacturer(s): Sandoz Inc
NDC(s): 0781-3450, 0781-3451
Route(s): INTRAMUSCULAR, INTRAVENOUS, PARENTERAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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