FDA Recall D-0626-2025
Sandoz Inc · Princeton, NJ
Class II Ongoing 274 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Temperature Abuse
Recall record
- Recall number
D-0626-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed to one consignee in CA.
- Recall initiated
- 2025-08-13
- Classified by FDA Center
- 2025-09-10
- FDA published
- 2025-09-17
- Recalling firm
- Sandoz Inc
- Firm location
- Princeton, NJ
Drug identification
- Brand name(s)
- CIPROFLOXACIN AND DEXAMETHASONE
- Generic name(s)
- CIPROFLOXACIN AND DEXAMETHASONE
- Manufacturer(s)
- Sandoz Inc
- NDC(s)
0781-6186- Route(s)
- AURICULAR (OTIC)
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.