Ciprofloxacin 0 recalled over temperature-control failures

Recall date

August 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sandoz Inc recalls Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manu…

Recall number

D-0626-2025

FDA classification

Class II

Brand / firm

Sandoz Inc

Sold / distributed

Product was distributed to one consignee in CA.

Why it was recalled

Temperature Abuse

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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