Information
SUN PHARMACEUTICAL INDUSTRIES INC Recalls Clindamycin Phosphate USP
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0257-2026Drug / Pharmaceutical
SUN PHARMACEUTICAL INDUSTRIES INC Recalls Clindamycin Phosphate USP
SUN PHARMACEUTICAL INDUSTRIES INC · Class III — Regulatory
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.
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
Nationwide in the USA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class III recall — the lowest severity level — for a pharmaceutical product recalled by SUN PHARMACEUTICAL INDUSTRIES INC on November 26, 2025. Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. The product was distributed nationwide. Class III recalls typically involve products unlikely to cause health problems but that violate FDA manufacturing or labeling regulations.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.