Fluocinolone Acetonide Solution Topical Solution USP recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIIOngoing
Summary: SUN PHARMACEUTICAL INDUSTRIES INC is recalling 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.
What is being recalled
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
Why
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
Nationwide within the USA
How to tell if yours is affected
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0256-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | December 30, 2025 |
| Reported | January 21, 2026 |
| Company | SUN PHARMACEUTICAL INDUSTRIES INC |
| Company location | Princeton, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 24,624 bottles |
More recalls from SUN PHARMACEUTICAL INDUSTRIES INC · all drug recalls · recalls from December 2025