Drug recall
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By…
FDA recall event 97431 · Class II · Sandoz Inc
Key facts
| Event ID | 97431 |
|---|---|
| Recall numbers | D-0626-2025 |
| Recalling firm | Sandoz Inc |
| Product type | Drugs |
| Products | 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#… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Temperature Abuse |
| Initiation date | Aug 13, 2025 |
| Report date | Sep 17, 2025 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3011552892 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: