Quick Facts at a Glance
- Recall Date
- November 26, 2025
- Hazard Level
- HIGH
- Brands
- CLINDAMYCIN PHOSPHATE, Taro Pharmaceuticals U.S.A., Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CLINDAMYCIN PHOSPHATE, Taro Pharmaceuticals U.S.A., Inc.
- Product type
- Topical Solution
- Model numbers
- Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
- UPC codes
- 51672-4081, 51672-4081-3, 51672-4081-4
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 26, 2025
Reported by FDA DRUG
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact SUN PHARMACEUTICAL INDUSTRIES INC or your healthcare provider for guidance. Notification method: Letter
About This Product
Clindamycin Phosphate is a topical antibiotic used to treat acne and other skin infections. Consumers purchase it for its efficacy in reducing bacterial growth on the skin.
Why This Is Dangerous
The impurity issues can affect the product's effectiveness and may lead to unwanted side effects or treatment failures. Using a compromised medication can have significant health implications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects consumers' ability to manage their skin conditions effectively. Stopping use may lead to worsening symptoms or require alternative treatments.
Practical Guidance
How to identify if yours is affected
- Check the lot number on your Clindamycin Phosphate bottle.
- If the lot number is AD30154, AD31143, or AD31145, the product is recalled.
- Verify the expiration date, which should be November 30, 2025.
Where to find product info
Lot numbers are usually printed on the label or packaging of the product.
What timeline to expect
Expect 4-6 weeks for processing refunds or replacements after contacting the company.
If the manufacturer is unresponsive
- Contact your healthcare provider for assistance.
- Reach out to FDA for reporting issues.
- Keep a record of your communications.
How to prevent similar issues
- Look for FDA approval and testing history when purchasing medications.
- Check for recalls regularly via the FDA website.
- Consult with your healthcare provider before starting new medications.
Documentation advice
Keep all receipts and correspondence regarding the recall for your records.
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Product Details
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.
Key Facts
- Recalled product: Clindamycin Phosphate USP, 1%
- Affected lot numbers: AD30154, AD31143, AD31145
- Expiration date: November 30, 2025
- Stop using the product immediately
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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