Unrated Drug recall · FDA · Published November 26, 2025

SUN PHARMACEUTICAL Clindamycin Phosphate Topical Solution Recall: Impurities Risk

SUN PHARMACEUTICAL recalls Clindamycin Phosphate topical solution due to impurities and degradation. This medication is prescription-only and may pose risks if used improperly.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0257-2026Drug SUN PHARMACEUTICAL INDUSTRIES INC ›

Recall notice

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

Take action

Contact the company

Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC2 Independence Way · Princeton, NJ 08540-6620

✎ GovInfoNow plain-language explainer

SUN PHARMACEUTICAL is recalling prescription clindamycin phosphate topical solution because it contains impurities and degrades out of specification. This could affect medication safety and effectiveness. Read more at govinfonow.com/recall/31629-sun-pharmaceutical-clindamycin-phosphate-topical-solution-recall-impurities-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31629-sun-pharmaceutical-clindamycin-phosphate-topical-solution-recall-impurities-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0257-2026

Cite this page

“SUN PHARMACEUTICAL Clindamycin Phosphate Topical Solution Recall: Impurities Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31629-sun-pharmaceutical-clindamycin-phosphate-topical-solution-recall-impurities-risk. Based on FDA recall #D-0257-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0257-2026%22&limit=1).

The FDA announced on 2025-11-26 that SUN PHARMACEUTICAL INDUSTRIES INC is recalling Clindamycin Phosphate USP, 1% Topical Solution due to out-of-specification impurities and assay results. The voluntary Class III recall affects specific lots distributed nationwide.

How to tell if you have it

Brand: SUN PHARMACEUTICAL INDUSTRIES INC
Product: Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle
NDC#: 51672-4081-4
Lot codes: AD30154, AD31143, AD31145
Expiration date: 11/30/2025

The hazard

The recall addresses failed impurities and degradation, specifically out-of-specification results for total impurities and assay. The FDA classifies this as a Class III recall.

Context

GovInfoNow's records show SUN PHARMACEUTICAL INDUSTRIES INC has 93 other recalls on record since 2013-05-21. Other recent recalls of similar products include Sun Pharmaceutical Nystatin Cream Recall (2026-09-14), Sun Pharmaceutical Carbamazepine Tablets Recall (2026-08-03), and Sun Pharmaceutical Perampanel 6mg Tablets Recall (2026-06-17). Other recent recalls of similar products include Somerset Therapeutics Dexamethasone Injection Recall (2026-02-04), Heritage Pharma Recalls Clindamycin Oral Solution Due to Foreign Particles (2026-07-30), and Baxter Clindamycin Injection Recall (2026-08-06).

How to tell if you have this one

Check for the product name 'Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle'. Look for lot numbers AD30154, AD31143, or AD31145 with expiration date 11/30/2025.

Brand
SUN PHARMACEUTICAL INDUSTRIES INC
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the lot number and expiration date on the product label to confirm if it's recalled.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 56 days after the firm started it.

Nov 26, 2025Firm started the recall
Jan 14, 2026FDA classified it Class III
Jan 21, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other SUN PHARMACEUTICAL INDUSTRIES INC recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31629-sun-pharmaceutical-clindamycin-phosphate-topical-solution-recall-impurities-risk">SUN PHARMACEUTICAL Clindamycin Phosphate Topical Solution Recall: Impurities Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0257-2026 (November 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0257-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.