Recalls / Class III
Class IIID-0257-2026
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
- Brand name
- Clindamycin Phosphate
- Generic name
- Clindamycin Phosphate
- Active ingredient
- Clindamycin Phosphate
- Route
- Topical
- NDC
- 51672-4081
- FDA application
- ANDA065184
- Affected lot / code info
- Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
Why it was recalled
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2025-11-26
- FDA classified
- 2026-01-14
- Posted by FDA
- 2026-01-21
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0257-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.