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Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only,...

FDA Recall #D-0257-2026 — Class III — November 26, 2025

Recall #D-0257-2026 Date: November 26, 2025 Classification: Class III Status: Ongoing

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.

Recalling Firm

SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Distribution

Nationwide in the USA.

Code Information

Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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