Taro Pharmaceuticals recalled Clindamycin Phosphate USP, 1% topical solution on November 26, 2025. The recall affects specific lots due to failed impurity testing. Consumers should stop using the product immediately and consult healthcare providers.
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Consumers and healthcare providers should stop using this product immediately. Contact SUN PHARMACEUTICAL INDUSTRIES INC or your healthcare provider for guidance. Notification method: Letter
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The recalled product is Clindamycin Phosphate USP, 1% (10 mg/mL) topical solution, packaged in 60 mL applicator bottles. It was distributed nationwide in the USA. The affected lot numbers include AD30154, AD31143, and AD31145, with expiration date of November 30, 2025.
The recall stems from out-of-specification results for total impurities and assay levels. These issues may affect the product's efficacy and safety, potentially leading to adverse health effects.
There have been no reported injuries or incidents associated with the recalled product. The recall is classified as Class III, indicating a low risk of serious health consequences.
Consumers should stop using Clindamycin Phosphate immediately. Contact SUN PHARMACEUTICAL INDUSTRIES INC for guidance and further instructions.
For more information, consumers can visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0257-2026 or contact their healthcare provider.
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