D-0257-2026 Class III Ongoing
FDA drug recall D-0257-2026 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on November 26, 2025 and is designated Class III. Reason for recall: Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- January 21, 2026
- Initiation Date
- November 26, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025