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

FDA recall notice · announced January 21, 2026 · Sun Pharmaceutical Industries

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
Status: Ongoing
Products in this recall event:
- 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, I (D-0257-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.