Sandoz Inc

6 FDA enforcement actions

6 Total Recalls

3 Class I

3 Class II

0 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 09/05/2025 drug

cGMP deviations: Temperature excursion during transportation.
Class II: Risk 08/13/2025 drug

Temperature Abuse
Class I: Dangerous 06/27/2025 drug

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
Class I: Dangerous 06/27/2025 drug

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 II: Risk 03/21/2022 drug

CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Class I: Dangerous 11/17/2021 drug

Temperature Abuse; temperature excursion during shipping

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.