FDAClass IIRecall started August 13, 2025

Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Recall

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

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was Ciprofloxacin 0.3% recalled?

Temperature Abuse

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

Which lot codes, UPCs or models are affected?

Lot # VNF35A, Exp.08/31/2026

Agency record number: D-0626-2025
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
Recalling firm: Sandoz Inc
Quantity: 1,680 bottles
Distribution: Product was distributed to one consignee in CA.
Recall started: August 13, 2025
Report date: September 17, 2025
Classification: Class II
Status: Ongoing
Agency: FDA (drug)

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