Why it was recalled
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Product description
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
Lot numbers, UPCs & expiration codes
Lot # PG4360, PG4362, Exp. 11/30/2027
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0569-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jun 27, 2025
- FDA report date
- Jul 9, 2025
- Quantity
- 208,300 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0569-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97140
- Address
- 100 College Rd W
- Code information
- Lot # PG4360, PG4362, Exp. 11/30/2027
- Postal code
- 08540-6604
- Report date
- Jul 9, 2025
- Product type
- Drugs
- Recall number
- D-0569-2025
- Classification
- Class I
- Recalling firm
- Sandoz Inc
- Product quantity
- 208,300 vials
- Reason for recall
- Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 27, 2025
- Initial firm notification
- Press Release
- Center classification date
- Aug 6, 2025