CIPROFLOXACIN AND DEXAMETHASONE
Recalling Firm / Manufacturer: Sandoz Inc
(Princeton, NJ, United States)
FDA Recall Number: D-0626-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
CIPROFLOXACIN AND DEXAMETHASONE
Generic Name
CIPROFLOXACIN AND DEXAMETHASONE
Active Substance(s)
Ciprofloxacin Hydrochloride, Dexamethasone
Administration Route
Auricular (otic)
National Drug Code (NDC)
0781-6186
Total Quantity Recalled
1,680 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Temperature Abuse
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
September 17, 2025
Firm Initiation Date
August 13, 2025
FDA Classification Date
Sep 10, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # VNF35A, Exp.08/31/2026
Distribution Information
Geographic scope of affected shipments
Product was distributed to one consignee in CA.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0626-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508613UTCC