FDA recall D-0257-2026

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.

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2025-11-26

Report date

2026-01-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0257-2026