PlainRecalls
FDA Drug Low Class III Ongoing

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

Reported: January 21, 2026 Initiated: November 26, 2025 #D-0257-2026

Product Description

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

Reason for Recall

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

Details

Distribution
Nationwide in the USA.
Location
Princeton, NJ

Frequently Asked Questions

What product 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. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC.
Why was this product recalled?
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 21, 2026. Severity: Low. Recall number: D-0257-2026.