Recall archive / FDA company announcement

Sandoz: Cefazolin for Injection, USP, 1 gm vial — FDA announcement Jul 15, 2025

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Jul 15, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Cefazolin for Injection, USP, 1 gm vial
Reason: Vials incorrectly labelled as Penicillin G Potassium for Injection contain Cefazolin for Injection
Classification: Not supplied
Recalling firm: Sandoz, Inc.
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: cccec4247cbd82f2

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE - Princeton, NJ – July 15, 2025 – Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin for Injection, USP, 1 gram per vial. The lot is being recalled due to a customer complaint indicating that four (4) vials incorrectly labelled as Penicillin G Potassium for Injection, USP, 20 million Units were included in cartons (25 vials per carton) of Cefazolin for Injection, USP 1 gram per vial product. Sandoz has confirmed that the vials incorrectly labelled as Penicillin G Potassium for Injection contain Cefazolin for Injection, USP, 1 gram per vial.; Sandoz is notifying its customers by letter and is arranging for return of the recalled product. The product being recalled was shipped to select wholesalers for further distribution nationwide. Healthcare providers and customers who have this product should immediately stop use of this lot only and contact Sedgwick, the Sandoz Reverse Distributor, directly by phone at (844) 265-7409 or by email at [email protected].; Note: The photos represent images of Lot PG4360. Potential mislabeling of Lot PG4362 would appear in a similar manner, except for the lot number printed on the packaging, which would read PG4362.; Product Name \| Vial NDC \| Carton NDC \| Lot Number \| Expiration Date \| Manufacturer \| Distributor; Cefazolin for Injection, USP (25 by 1g vials) \| 0781-3451-70 \| 0781-3451-96 \| PG4360 \| 2027-NOV \| Sandoz GmbH \| Sandoz Inc; Penicillin G Potassium for Injection, USP \| 0781-6136-94 \| N/A \| PG4360 \| 2027-NOV \| Sandoz GmbH \| Sandoz Inc; Cefazolin for Injection, USP (25 by 1g vials) \| 0781-3451-70 \| 0781-3451-96 \| PG4362 \| 2027-NOV \| Sandoz GmbH \| Sandoz Inc; Penicillin G Potassium for Injection, USP \| 0781-6136-94 \| N/A \| PG4362 \| 2027-NOV \| Sandoz GmbH \| Sandoz Inc

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE - Princeton, NJ – July 15, 2025 – Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin for Injection, USP, 1 gram per vial. The lot is being recalled due to a customer complaint indicating that four (4) vials incorrectly labelled as Penicillin G Potassium for Injection, USP, 20 million Units were included in cartons (25 vials per carton) of Cefazolin for Injection, USP 1 gram per vial product. Sandoz has confirmed that the vials incorrectly labelled as Penicillin G Potassium for Injection contain Cefazolin for Injection, USP, 1 gram per vial.; Sandoz is notifying its customers by letter and is arranging for return of the recalled product. The product being recalled was shipped to select wholesalers for further distribution nationwide. Healthcare providers and customers who have this product should immediately stop use of this lot only and contact Sedgwick, the Sandoz Reverse Distributor, directly by phone at (844) 265-7409 or by email at [email protected].; Note: The photos represent images of Lot PG4360. Potential mislabeling of Lot PG4362 would appear in a similar manner, except for the lot number printed on the packaging, which would read PG4362.; Product Name | Vial NDC | Carton NDC | Lot Number | Expiration Date | Manufacturer | Distributor; Cefazolin for Injection, USP (25 by 1g vials) | 0781-3451-70 | 0781-3451-96 | PG4360 | 2027-NOV | Sandoz GmbH | Sandoz Inc; Penicillin G Potassium for Injection, USP | 0781-6136-94 | N/A | PG4360 | 2027-NOV | Sandoz GmbH | Sandoz Inc; Cefazolin for Injection, USP (25 by 1g vials) | 0781-3451-70 | 0781-3451-96 | PG4362 | 2027-NOV | Sandoz GmbH | Sandoz Inc; Penicillin G Potassium for Injection, USP | 0781-6136-94 | N/A | PG4362 | 2027-NOV | Sandoz GmbH | Sandoz Inc

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
Product Name	Vial NDC	Carton NDC	Lot Number	Expiration Date	Manufacturer	Distributor
Cefazolin for Injection, USP (25 by 1g vials)	0781-3451-70	0781-3451-96	PG4360	2027-NOV	Sandoz GmbH	Sandoz Inc
Penicillin G Potassium for Injection, USP	0781-6136-94	N/A	PG4360	2027-NOV	Sandoz GmbH	Sandoz Inc
Cefazolin for Injection, USP (25 by 1g vials)	0781-3451-70	0781-3451-96	PG4362	2027-NOV	Sandoz GmbH	Sandoz Inc
Penicillin G Potassium for Injection, USP	0781-6136-94	N/A	PG4362	2027-NOV	Sandoz GmbH	Sandoz Inc

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Sandoz is notifying its customers by letter and is arranging for return of the recalled product. The product being recalled was shipped to select wholesalers for further distribution nationwide. Healthcare providers and customers who have this product should immediately stop use of this lot only and contact Sedgwick, the Sandoz Reverse Distributor, directly by phone at (844) 265-7409 or by email at [email protected].

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Fda listing date: Jul 15, 2025
Company announcement date: Jul 15, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.