Clindamycin topical solution recalled after failing impurity and assay specifications
Sun Pharmaceutical Industries is recalling Clindamycin Phosphate Topical Solution 1% after out of specification results for total impurities and for assay.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites out of specification impurity and assay results with no stated clinical consequence.
Plain-English summary
Clindamycin Phosphate USP, 1% (10 mg/mL) Topical Solution, 60 mL per applicator bottle, manufactured by Taro Pharmaceutical Industries Ltd. of Haifa Bay, Israel and distributed by Taro Pharmaceuticals USA, Inc. of Hawthorne, New York, under NDC 51672-4081-4, is being recalled.
The reason given in the enforcement record is failed impurities and degradation: out of specification results for total impurities and for assay.
The recall covers lots AD30154, AD31143 and AD31145, all expiring 11/30/2025. The record does not state a quantity. Distribution was nationwide in the USA. The FDA has classified the action as Class III, its least serious category.
Patients should not stop using a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
- Brand
- CLINDAMYCIN PHOSPHATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Topical antibiotic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot#: AD30154
- AD31143
- AD31145
- Exp 11/30/2025
UPCs (1)
- 0351672408138
Distribution
Distributed nationwide across the United States.
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