Quick Facts at a Glance
- Recall Date
- August 13, 2025
- Hazard Level
- HIGH
- Brands
- CIPROFLOXACIN AND DEXAMETHASONE, Sandoz Inc, Novartis Manufacturing NV
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CIPROFLOXACIN AND DEXAMETHASONE, Sandoz Inc, Novartis Manufacturing NV
- Product type
- Otic suspension
- Model numbers
- Lot # VNF35A, Exp.08/31/2026, NDC# 0781-6186-67, Carton NDC# 0781-6186-67
- UPC codes
- 0781-6186, 0781-6186-67
- Sold at
- Unknown
- Where affected
- CA
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 13, 2025
Reported by FDA DRUG
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Temperature Abuse
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Sandoz Inc or your healthcare provider for guidance. Notification method: Letter
About This Product
Otic suspension used for ear infections in humans. Rx only. Requires prescription and medical oversight.
Why This Is Dangerous
Temperature abuse may compromise product integrity, potency, or sterility depending on storage conditions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Immediate halt on use and coordination with healthcare providers needed to avoid compromised treatment.
Practical Guidance
How to identify if yours is affected
- Check NDC 0781-6186-67 on the packaging.
- Check Lot # VNF35A and Exp. 08/31/2026.
- Verify distributor: Sandoz, Inc., Princeton, NJ.
Where to find product info
FDA recall page for D-0626-2025; product packaging and patient information leaflet.
What timeline to expect
Refund/replacement process to be defined in mailed notification over weeks.
If the manufacturer is unresponsive
- Escalate with consumer protection agencies
- File complaint with FDA medwatch if safety concerns persist
How to prevent similar issues
- Store otic suspensions per label instructions
- Avoid temperature abuse during shipping and storage
- Verify NDC and lot numbers before dispensing or using
Documentation advice
Keep packaging, lot number, expiration, and recall notice; record dates and communications
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Product Details
Product: Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only. Manufactured by: Novartis Manufacturing NV, Belgium. Distributed by: Sandoz, Inc., Princeton, NJ. NDC# 0781-6186-67. Carton NDC# 0781-6186-67. Lot: VNF35A. Expiration: 08/31/2026. Quantity: 1,680 bottles. Distribution: CA only.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Lot # VNF35A
- Distribution limited to California
- Recall status: ACTIVE
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Safety Guide
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