FDA Drug recall D-0257-2026
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries L…
- FDA Drug
- Class III
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class III recall of Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries L… by Sun Pharmaceutical Industries, citing failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0257-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-11-26 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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.
Identifiers
| ndc | 51672-4081-3 |
|---|---|
| ndc | 51672-4081-4 |
| code_info | Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0257-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.