Sandoz Inc recalls Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, M…

Recall date

June 27, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0570-2025

FDA classification

Class I

Brand / firm

Sandoz Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.