Drug FDA Class I Ongoing Mislabeling

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.

Sandoz Inc Published Jul 9, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Sandoz Inc or your place of purchase with questions, and see the source record below for full details.

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

Affected products (1)

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.

PENICILLIN G POTASSIUM · unknown

NDC: 0781-6135, 0781-6136, 0781-6135-94, 0781-6135-95, 0781-6136-94

Lot codes: PG4360

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

Affected areas

Nationwide

Timeline

Initiated

Jun 27, 2025
Published

Jul 9, 2025

Recall number: D-0570-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.