FDA Drug recall D-0256-2026
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532
- FDA Drug
- Class III
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class III recall of Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532 by Sun Pharmaceutical Industries, citing failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0256-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-12-30 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
Reason
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Identifiers
| ndc | 51672-1365-2 |
|---|---|
| ndc | 51672-1365-4 |
| code_info | Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0256-2026%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.