Use cautionDrug recall · FDA · Published August 13, 2025
Sandoz Ciprofloxacin Otic Suspension Recall: Temperature Abuse Risk
Sandoz recalls Ciprofloxacin 0.3% and Dexamethasone 0.1% ear drops due to temperature abuse risks. This prescription-only ear medication may cause injury if stored or used improperly.
“Sandoz Ciprofloxacin Otic Suspension Recall: Temperature Abuse Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31873-sandoz-ciprofloxacin-otic-suspension-recall-temperature-abuse-risk. Based on FDA recall #D-0626-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0626-2025%22&limit=1).
Sandoz Inc recalled Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension due to temperature abuse hazards, the FDA announced on Aug. 13, 2025. The voluntary Class II recall affects 1,680 bottles distributed to one consignee in California.
How to tell if you have it
Brand: Sandoz
Product: Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only
Manufacturer: Novartis Manufacturing NV, Belgium
Distributor: Sandoz, Inc., Princeton, NJ
NDC#: 0781-6186-67
Carton NDC#: 0781-6186-67
Lot #: VNF35A
Expiration: 08/31/2026
Quantity: 1,680 bottles
The hazard
The recall is due to temperature abuse of the otic suspension. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Sandoz Inc has 29 other recalls on record since Oct. 9, 2013. Other recent recalls include Sandoz Focalin XR 5mg Capsules (June 1, 2026), Sandoz Cyclophosphamide Injection (Sept. 5, 2025), and Sandoz Cefazolin Injection (June 27, 2025). Other recent recalls of similar products include TerSera Zoladex Implants (Aug. 31, 2026), McKesson Gemcitabine Injection (June 10, 2026), and McKesson UDENYCA Injection (Jan. 16, 2026).
How to tell if you have this one
Check for the NDC code 0781-6186-67 on the carton and lot number VNF35A. This prescription-only ear drop was manufactured in Belgium and distributed by Sandoz in Princeton, New Jersey.
Brand
Sandoz
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Storage Conditions
Ensure the medication is stored at room temperature away from direct sunlight and moisture.
Verify Product Details
Confirm the NDC code 0781-6186-67 and lot number VNF35A on the carton.
Where it went and when
Where it was distributed
Distributed in California.
Listed by the agency
Not listed
FDA distribution: “Product was distributed to one consignee in CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0626-2025 (August 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0626-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.