Drug FDA Class III Ongoing Failed specifications

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

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: Out of Specification results for Total Impurities and for Assay.

Hazards

Failed Assay and Total Impurities Specifications · primary

Affected products (1)

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

CLINDAMYCIN PHOSPHATE

NDC: 51672-4081, 51672-4081-3, 51672-4081-4

Code info: Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025

Affected areas

Nationwide

Timeline

Initiated

Nov 26, 2025
Published

Jan 21, 2026

Recall number: D-0257-2026
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.