Sandoz Ciprofloxacin-Dexamethasone Otic Suspension Recall Due to Temperature Exposure
Sandoz voluntarily recalls 1,680 bottles of Ciprofloxacin and Dexamethasone otic suspension due to temperature exposure that may have affected medication stability. The product was distributed to a single customer in California.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II voluntary precautionary recall with no reported adverse events. The hazard is temperature-related potential degradation of medication efficacy and stability. The recall criteria fits 'voluntary precautionary recalls' under the Moderate category, as no hospitalizations, injuries, or illnesses have been reported.
Plain-English summary
Sandoz Inc. is voluntarily recalling 1,680 bottles of Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension (Lot VNF35A, expiration 08/31/2026, NDC 0781-6186-67). This is a prescription otic suspension used in the treatment of ear conditions.
The recall is due to temperature abuse during storage and distribution. Exposure to improper temperatures may have compromised the medication's stability and efficacy, potentially affecting the product's performance.
The affected product was distributed to one customer in California. Sandoz initiated the recall on August 13, 2025, and the FDA classified it as Class II on September 10, 2025.
Patients and healthcare providers with this product should discontinue use immediately and contact Sandoz or their healthcare provider for replacement or alternative treatment options. Do not dispose of medication in household trash or water; use a medication take-back program if available.
The recalled product
- Product
- CIPROFLOXACIN AND DEXAMETHASONE (CIPROFLOXACIN AND DEXAMETHASONE)
- Brand
- CIPROFLOXACIN AND DEXAMETHASONE
- Manufacturer
- Sandoz Inc
- Category
- Drug — Otic Suspension
- Hazard
- temperature-abuse
- medication-degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # VNF35A
- Exp.08/31/2026
UPCs (1)
- 0307816186677
Distribution
Distributed in 1 state:
- CA
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