CLASS II ONGOING Drug recall · Reported 17 Sep 2025 · FDA Enforcement Report
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalled
Sandoz is recalling Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, distributed in California. The recall was initiated on 13 Aug 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0626-2025
- FDA event ID
- 97431
- Recalling firm
- Sandoz, Princeton, NJ
- Manufacturer
- Sandoz Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Aug 2025
- FDA classified
- 10 Sep 2025
- Reported
- 17 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Antibiotics
Timeline
| 13 Aug 2025 | Recall initiated by company | |
| 10 Sep 2025 | Classified by FDA | +28 days |
| 17 Sep 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature Abuse
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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
Where it was distributed
Product was distributed to one consignee in CA.
Questions about this recall
Why was it recalled?
Temperature Abuse
Which lots are affected?
Lot # VNF35A, Exp.08/31/2026
Where was it sold?
Product was distributed to one consignee in CA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Ciprofloxacin recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package recalledCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base recalled by FDCCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin ophthalmic solution USP, 0.3% as base recalled by FDCCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl) recalled | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution recalled by Mckesson Medical-SurgicalCiprofloxacin Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |