FDA DrugsClass III
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx o...
Published: January 21, 2026Recall ID: D-0256-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Openfda › Nui › 1 | N0000175576 |
| Openfda › Nui › 2 | N0000175450 |
| Openfda › Unii | 0CD5FD6S2M |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 1191310 |
| Openfda › Spl id | 390af125-04e3-1010-e063-6294a90a016d |
| Openfda › Brand name | FLUOCINOLONE ACETONIDE |
| Openfda › Spl set id | 02352ed1-3568-441f-add8-45201351a11c |
| Openfda › Package ndc › 1 | 51672-1365-2 |
| Openfda › Package ndc › 2 | 51672-1365-4 |
| Openfda › Product ndc | 51672-1365 |
| Openfda › Generic name | FLUOCINOLONE ACETONIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | FLUOCINOLONE ACETONIDE |
| Openfda › Pharm class epc | Corticosteroid [EPC] |
| Openfda › Pharm class moa | Corticosteroid Hormone Receptor Agonists [MoA] |
| Openfda › Manufacturer name | Sun Pharmaceutical Industries, Inc. |
| Openfda › Application number | ANDA089124 |
| Openfda › Is original packager | true |
| Event id | 98241 |
| Address 1 | 2 Independence Way |
| Code info | Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027 |
| Postal code | 08540-6620 |
| Report date | 20260121 |
| Product type | Drugs |
| Product quantity | 24,624 bottles |
| Reason for recall | Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251230 |
| Initial firm notification | Letter |
| Center classification date | 20260113 |
Overview
- Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
- StatusOngoing
- Risk LevelClass III
- DistributionNationwide within the USA