FDA Drug recall D-0626-2025
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgiu…
- FDA Drug
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgiu… by Sandoz, citing temperature Abuse.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0626-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-13 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sandoz |
| Distribution | CA |
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
Temperature Abuse
Identifiers
| ndc | 0781-6186-67 |
|---|---|
| code_info | Lot # VNF35A, Exp.08/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0626-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.