Drug FDA Class III Ongoing Failed specifications

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

SUN PHARMACEUTICAL INDUSTRIES INC Published Jan 21, 2026

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact SUN PHARMACEUTICAL INDUSTRIES INC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

Hazards

Impurity D · primary

Affected products (1)

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

FLUOCINOLONE ACETONIDE · 24,624 bottles

NDC: 51672-1365, 51672-1365-2, 51672-1365-4

Code info: Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027

Affected areas

Nationwide

Timeline

Initiated

Dec 30, 2025
Published

Jan 21, 2026

Recall number: D-0256-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.