SUN PHARMACEUTICAL INDUSTRIES INC recalls Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmac…

Recall date

November 26, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0257-2026

FDA classification

Class III

Brand / firm

SUN PHARMACEUTICAL INDUSTRIES INC

Sold / distributed

Nationwide in the USA.

Why it was recalled

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4