FDA Drugs recall ·
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution… recall
- Recall number
- D-0257-2026
- Date
- (initiated November 26, 2025)
- Company / brand
- Sun Pharmaceutical Industries Inc
2 Independence Way, Princeton, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
Distribution
Nationwide in the USA.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0257-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.