Topical Antibiotic Clindamycin Phosphate Recalled for Out-of-Specification Impurities
SUN Pharmaceutical recalls Clindamycin Phosphate 1% topical solution nationwide due to failed quality control tests showing out-of-specification impurities and assay results. Affected lots should be discontinued.
What this means for you
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: This recall is classified as Moderate (Score 2) because it is an FDA Class III recall with no reported illnesses or injuries. The hazard is based on quality control failures rather than an imminent safety threat. FDA Class III recalls with no reported harm are typically scored 1–2.
Plain-English summary
SUN Pharmaceutical Industries Inc. is recalling Clindamycin Phosphate USP 1% (10 mg/mL) topical solution in 60 mL applicator bottles due to failed quality control testing. The product failed testing for total impurities and assay results, indicating that the medication does not meet required pharmaceutical standards.
The recalled product includes lot numbers AD30154, AD31143, and AD31145, with expiration date November 30, 2025. It was distributed nationwide throughout the USA. The affected product has NDC# 51672-4081-4 and UPC 0351672408138.
Consumers who have this product should stop using it and consult their healthcare provider about obtaining a replacement from a different lot. Healthcare providers and patients should verify lot numbers before dispensing or using this medication.
The recalled product
- Product
- CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
- Brand
- CLINDAMYCIN PHOSPHATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Topical Antibiotic
- Hazard
- impurity
- degradation
- potency-defect
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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