The Recall Desk
ModerateFDA (Drugs)·D-0626-2025·Announced 2025-09-17

Ciprofloxacin and dexamethasone otic suspension recalled following temperature abuse

Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, lot VNF35A, distributed by Sandoz, is recalled because of temperature abuse. 1,680 bottles went to a single consignee 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: Rubric level 2 covers precautionary recalls; the notice states only that the product experienced temperature abuse, without describing any consequence.

Plain-English summary

Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, for use in ears only and available on prescription, manufactured by Novartis Manufacturing NV in Belgium and distributed by Sandoz, Inc. of Princeton, New Jersey, NDC 0781-6186-67, is being recalled. The affected product is lot VNF35A with an expiry of 08/31/2026, and the recall covers 1,680 bottles distributed to one consignee in California.

The recall was issued because of temperature abuse. The FDA classified the action as Class II. The notice does not describe a further consequence.

Patients and pharmacies holding this lot should follow the distributor's instructions for return, and patients should speak to their pharmacist about a replacement supply.

The recalled product

Product
CIPROFLOXACIN AND DEXAMETHASONE (CIPROFLOXACIN AND DEXAMETHASONE)
Brand
CIPROFLOXACIN AND DEXAMETHASONE
Manufacturer
Sandoz Inc
Affected units
1,680

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: