Reported Jan 21, 2026 · Ongoing
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals…
Sun Pharmaceutical Industries Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist
- byTaro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
- Lot codes and dates
Lot #: AD81290AD81291AD81292 and AD81293Exp. Date 1/31/2027
- Amount recalled
- 24,624 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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