United StatesFluocinolone acetonide topical solution USP, 0.01%, 60‑mL bottles (Rx only), distributed by Taro Pharmaceuticals, NDC 51672‑1365‑4, lots AD81290, AD81291, AD81292 and AD81293, exp. 01/31/2027, is being recalled nationwide. The product was recalled because it failed impurities/degradation specifications with an out‑of‑specification result for the known impurity D.
What's 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
Recalling firm: Sun Pharmaceutical Industries Inc, Princeton, NJ, United States.
How to identify it
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
The hazard
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)