August 2025 FDA Recall Ciprofloxacin And Dexamethasone by Sandoz Inc
D-0626-2025 - Temperature Abuse
This Class II drug recall was voluntarily initiated by Sandoz Inc on August 13, 2025 for the product Ciprofloxacin And Dexamethasone. The FDA reported the reason for recall as temperature abuse. The product was distributed in Product was distributed to one consignee in CA. and the recall is currently ongoing.
Recall Number: D-0626-2025
Temperature Abuse
08-13-2025
09-17-2025
1,680 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sandoz Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to one consignee in CA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# VNF35A, Exp.08/31/2026
