Sandoz Inc: Drug Recall

Recall #D-0626-2025 · 08/13/2025

Class II: Risk

Recall Details

Recall Number: D-0626-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Sandoz Inc
Status: Ongoing
Date Initiated: 08/13/2025
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,680 bottles

Reason for Recall

Temperature Abuse

Product Description

Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ, NDC# 0781-6186-67, Carton NDC# 0781-6186-67

Distribution Pattern

Product was distributed to one consignee in CA.

Other Recalls by Sandoz Inc

Class II: Risk 09/05/2025

cGMP deviations: Temperature excursion during transportation.
Class I: Dangerous 06/27/2025

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

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

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

Temperature Abuse; temperature excursion during shipping

View all recalls by Sandoz Inc →

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.