FDA Recall D-0570-2025

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

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.

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

Quantity: unknown

Reason for recall

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

Recall record

Recall number: D-0570-2025
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): PENICILLIN G POTASSIUM
Generic name(s): PENICILLIN G POTASSIUM
Manufacturer(s): Sandoz Inc
NDC(s): 0781-6135, 0781-6136
Route(s): INTRAMUSCULAR, INTRAVENOUS

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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