Skip to content
Back to recalls
Drug FDA Class II Ongoing Quality

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

Sandoz Inc Published Sep 17, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Sandoz Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Temperature Abuse

Affected products (1)

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

CIPROFLOXACIN AND DEXAMETHASONE · 1,680 bottles

NDC: 0781-6186, 0781-6186-67
Lot codes: VNF35A
Code info: Lot # VNF35A, Exp.08/31/2026

Affected areas

California

Timeline

  1. Initiated
    Aug 13, 2025
  2. Published
    Sep 17, 2025
Recall number
D-0626-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.