Class II U.S. Food and Drug Administration

Sandoz Inc Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recall: Temperature Abuse

Recall published 1+ years ago

Temperature Abuse

The hazard: Temperature control failure

The recall reflects a storage or transport failure rather than a contaminant found in testing.

What the notice says: Temperature Abuse

Why it matters: The product went outside its required temperature range in storage or transport. That does not prove bacteria grew in it, but it removes the control that was supposed to stop them.

Symptoms and when to call a doctor

If you have eaten it, watch for the usual food-poisoning pattern — stomach cramps, nausea, diarrhoea, sometimes fever — and seek care for a high fever, bloody stools, persistent vomiting or signs of dehydration.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0626-2025
Published
September 17, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Sandoz Inc
Product type
Prescription & OTC drugs
Units affected
1,680 bottles
Distribution
California
Made in
United States
Lot / code info
Lot # VNF35A, Exp.08/31/2026

Products covered by this 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

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • VNF35A
  • Exp.08
  • 31
  • 2026 — 1
  • 680 bottles

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 08
  • 31
  • 2026 — 1
  • 680 bottles

NDC number

On the carton and again on the bottle or blister label.

  • 0781-6186-67

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Temperature

Sandoz Inc — The recall reflects a storage or transport failure rather than a contaminant found in testing.

  1. Do not eat it, even if it looks and smells normal — that is exactly what the recall anticipates.
  2. Bin it sealed or return it for a refund using the lot code from the pack.
  3. Clean the shelf it sat on if any packaging has leaked.
  4. If you refroze it after it thawed, discard it rather than keeping it for cooking later.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: Sandoz Inc — 100 College Rd W, Princeton, NJ, 08540-6604

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Sandoz Inc prescription & otc drugs recalled?

Temperature Abuse Temperature Abuse

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code VNF35A, Exp.08, 31; best-by date 08 or 31. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Do not eat it, even if it looks and smells normal — that is exactly what the recall anticipates.

Can I get my money back?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Which states were affected?

The notice lists California.

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