Recall: D-0257-2026

Class III - Minor Violations

Class IIIClassification

2025-11-26Initiated

OngoingStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

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

Distribution

Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.