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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sandoz Cefazolin and Penicillin G Injection Recalled for Label Mix-Up

Agency Publication Date: August 6, 2025
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Summary

Sandoz Inc. has recalled approximately 208,300 vials of Cefazolin for Injection, USP (1 gram) and Buffered Penicillin G Potassium for Injection, USP (20 million units) because some vials were incorrectly labeled. Specifically, cartons containing Cefazolin were found with vials labeled as Penicillin, even though they contained Cefazolin. This label mix-up means patients may receive the wrong medication or an incorrect dosage. Consumers should contact their healthcare provider or the manufacturer immediately.

Risk

This mix-up could cause a patient to receive the wrong antibiotic or an incorrect dosage for their condition. Additionally, patients allergic to cephalosporins (the drug class for Cefazolin) who unknowingly receive it instead of Penicillin could suffer a severe, potentially life-threatening allergic reaction.

What You Should Do

  1. This recall affects Sandoz Cefazolin for Injection (1g) and Buffered Penicillin G Potassium for Injection (20 million units) with lot numbers PG4360 and PG4362, both with an expiration date of November 30, 2027.
  2. Stop using the recalled products immediately. Contact Sandoz Inc. or your medical distributor to arrange for the return of any remaining affected vials and cartons.
  3. If you are a patient and have health concerns related to these medications, contact your healthcare provider or pharmacist immediately.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Cefazolin for Injection, USP (1 gram per vial)by Sandoz
Variants: 1 gram per vial, Sterile
Lot Numbers:
PG4360 (Exp 11/30/2027)
PG4362 (Exp 11/30/2027)
NDC:
0781-3451-70
0781-3451-96
GTIN:
00307813451969

NDC 0781-3451-70 applies to the vial; NDC 0781-3451-96 applies to the carton.

Product: Buffered Penicillin G Potassium for Injection, USP (20 million units)by Sandoz
Variants: 20,000,000 Units, For IV use, Sterile
Lot Numbers:
PG4360 (Exp 11/30/2027)
PG4362 (Exp 11/30/2027)
NDC:
0781-6136-94

Product Images

Cefazolin for Injection, USP, 1 gram per vial, Rx only, 25 x 1 g Vials, Sandoz

Cefazolin for Injection, USP, 1 gram per vial, Rx only, 25 x 1 g Vials, Sandoz

LOT PG4360, EXP 2027-NOV

LOT PG4360, EXP 2027-NOV

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97140
Status: Active
Manufacturer: Sandoz Inc
Sold By: hospitals; clinics; medical wholesalers
Manufactured In: Austria
Units Affected: 2 products (208,300 vials; unknown)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.