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CLASS III · LowFDA

SUN PHARMACEUTICAL INDUSTRIES INC recalls Clindamycin Phosphate USP

📅 Nov 26, 2025 · 📍 Nationwide
Recalling company
SUN PHARMACEUTICAL INDUSTRIES INC
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.
Classification
Class III – not likely to cause adverse health consequences
Recall date
Nov 26, 2025
Reported
Jan 21, 2026
Distribution
Nationwide in the USA.
Status
Ongoing
Lot / codes
Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
Company location
Princeton, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0257-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0257-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.