Medications & Supplements/Topical Products

Clindamycin Phosphate Topical Solution Recalled for Impurity and Assay Issues

Agency Publication Date: January 14, 2026

Summary

Sun Pharmaceutical Industries Inc. has recalled several lots of Clindamycin Phosphate USP, 1% (10 mg/mL) Topical Solution, a prescription medication used to treat acne. The recall was initiated because testing revealed the product failed to meet specifications for total impurities and assay strength, meaning the drug may be less effective or contain higher-than-expected levels of degradation products. The medication is packaged in 60 mL applicator bottles and was distributed nationwide.

Risk

The drug failed 'out of specification' testing for impurities and potency, which may result in reduced effectiveness of the treatment or exposure to unintended chemical degradants.

What You Should Do

Identify your product by checking the bottle for Clindamycin Phosphate USP, 1% (10 mg/mL) in a 60 mL applicator bottle with NDC# 51672-4081-4.
Check the label for lot numbers AD30154, AD31143, or AD31145 with an expiration date of 11/30/2025.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution (60 mL)

Variants: Topical Solution, 1% (10 mg/mL)

Lot Numbers:

AD30154 (Exp 11/30/2025)

AD31143 (Exp 11/30/2025)

AD31145 (Exp 11/30/2025)

NDC:

51672-4081-4

Manufactured by Taro Pharmaceutical Industries Ltd.; Distributed by Taro Pharmaceuticals USA, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98062

Status: Active

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Retail Pharmacies

Manufactured In: Israel

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify your product by checking the bottle for Clindamycin Phosphate USP, 1% (10 mg/mL) in a 60 mL applicator bottle with NDC# 51672-4081-4.

Check the label for lot numbers AD30154, AD31143, or AD31145 with an expiration date of 11/30/2025.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution (60 mL)

Variants: Topical Solution, 1% (10 mg/mL)

Lot Numbers:

AD30154 (Exp 11/30/2025)

AD31143 (Exp 11/30/2025)

AD31145 (Exp 11/30/2025)

NDC:

51672-4081-4

Manufactured by Taro Pharmaceutical Industries Ltd.; Distributed by Taro Pharmaceuticals USA, Inc.