FDA Drugs recall ·
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only… recall
- Recall number
- D-0626-2025
- Date
- (initiated August 13, 2025)
- Company / brand
- Sandoz Inc
100 College Rd W, Princeton, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,680 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Temperature Abuse
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # VNF35A, Exp.08/31/2026
Distribution
Product was distributed to one consignee in CA.
States: California
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0626-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.