FDA recall, , Low risk
Taro Pharmaceuticals Fluocinolone Acetonide Topical Solution
Fluocinolone Acetonide Solution Topical Solution failed impurity specifications due to an out-of-specification result for known impurity D.
Summary by Recall Canary from the FDA notice
What happened
SUN PHARMACEUTICAL INDUSTRIES INC, of Princeton, New Jersey, recalled Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, distributed by Taro Pharmaceuticals Inc., Hawthorn, NY 10532, because an out-of-specification result was obtained for the known impurity D. The recall began December 30, 2025, and was added to the FDA's Enforcement Report on January 13, 2026.
The product was distributed nationwide within the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles
- NDC
- 51672-1365-4
- Lot code
- AD81290
- AD81291
- AD81292
- AD81293
Recall details
- Company began the recall
- Sold in
Nationwide within the USA
- Company
- SUN PHARMACEUTICAL INDUSTRIES INCPrinceton, New Jersey
- Hazard
- Drug impurity
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98241
- Recall number
- D-0256-2026
- Quantity recalled
- 24,624 bottles
All recalls from SUN PHARMACEUTICAL INDUSTRIES INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
