HIGH

Taro Pharmaceuticals Recalls Clindamycin Phosphate Over Impurities

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.

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

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

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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

  1. Check the lot number on your Clindamycin Phosphate bottle.
  2. If the lot number is AD30154, AD31143, or AD31145, the product is recalled.
  3. 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.

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot#: AD30154
AD31143
AD31145
Exp 11/30/2025
UPC Codes
51672-4081
51672-4081-3
51672-4081-4
Affected States
ALL
Report Date
January 21, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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