FDA DrugsClass III
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator...
Published: January 21, 2026Recall ID: D-0257-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Openfda › Upc | 0351672408138 |
| Openfda › Unii | EH6D7113I8 |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 309333 |
| Openfda › Spl id | 503c6717-9dad-2fd5-e063-6294a90a35f6 |
| Openfda › Brand name | CLINDAMYCIN PHOSPHATE |
| Openfda › Spl set id | 5b8a6767-2d46-401c-9f85-d427dda9eff7 |
| Openfda › Package ndc › 1 | 51672-4081-3 |
| Openfda › Package ndc › 2 | 51672-4081-4 |
| Openfda › Product ndc | 51672-4081 |
| Openfda › Generic name | CLINDAMYCIN PHOSPHATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | CLINDAMYCIN PHOSPHATE |
| Openfda › Manufacturer name | Sun Pharmaceutical Industries, Inc. |
| Openfda › Application number | ANDA065184 |
| Openfda › Is original packager | true |
| Event id | 98062 |
| Address 1 | 2 Independence Way |
| Code info | Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025 |
| Postal code | 08540-6620 |
| Report date | 20260121 |
| Product type | Drugs |
| Reason for recall | Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251126 |
| Initial firm notification | Letter |
| Center classification date | 20260114 |
Overview
- Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
- StatusOngoing
- Risk LevelClass III
- DistributionNationwide in the USA.