# FDA recall D-0626-2025

> **Sandoz Inc** · Class II · drug recall initiated 2025-08-13.

## 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

## Reason for recall

Temperature Abuse

## Distribution

Product was distributed to one consignee in CA.

## Key facts

- **Recall number:** D-0626-2025
- **Recalling firm:** Sandoz Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-13
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0626-2025

## Citation

> AI Analytics. FDA recall D-0626-2025. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/D-0626-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*