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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Ciprofloxacin and Dexamethasone Otic Suspension Recalled for Temperature Abuse

Agency Publication Date: September 10, 2025
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Summary

Sandoz Inc. is recalling 1,680 bottles of Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, an ear-drop medication used to treat ear infections. The recall was initiated due to "temperature abuse," meaning the product was exposed to temperatures outside of its required storage range during distribution. This exposure can compromise the stability and effectiveness of the medication. The affected products were distributed to a single consignee in California.

Risk

Exposure to improper temperatures can degrade the active ingredients or physical stability of the ear drops, potentially making the medication less effective at treating the underlying ear infection.

What You Should Do

  1. Check your medication bottle and carton for NDC number 0781-6186-67 and Lot # VNF35A with an expiration date of 08/31/2026.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension
Variants: Rx Only, For Use in Ears Only
Lot Numbers:
VNF35A (Exp.08/31/2026)
NDC:
0781-6186-67

Manufactured By: Novartis Manufacturing NV, Belgium; Distributed by: Sandoz, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97431
Status: Active
Manufacturer: Sandoz Inc
Sold By: Distributed to one consignee in CA
Manufactured In: Belgium, United States
Units Affected: 1,680 bottles
Distributed To: California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.