HIGHFDA DRUG

Trifecta Pharmaceuticals Recalls Clotrimazole Cream Over cGMP Issues

Trifecta Pharmaceuticals recalled 14,700 bottles of Globe Clotrimazole Cream USP on October 31, 2025, due to significant cGMP deviations. The affected product may not meet necessary safety and quality standards. Consumers should stop using the cream immediately and seek guidance from healthcare providers.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
October 31, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
October 31, 2025
Hazard Level
HIGH
Brands
CLOTRIMAZOLE, TRIFECTA PHARMACEUTICALS USA LLC
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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
CLOTRIMAZOLE, TRIFECTA PHARMACEUTICALS USA LLC
Product type
Antifungal Cream
Model numbers
Lot #: A472418
UPC codes
69396-087, 69396-087-01, 69396-087-55
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    October 31, 2025

  2. Reported by FDA DRUG

    December 10, 2025

  3. RecallRadar source check

    December 17, 2025

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

cGMP deviations

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Blossom Pharmaceuticals or your healthcare provider for guidance. Notification method: Letter

About This Product

Globe Clotrimazole Cream USP, 1% is an antifungal cream commonly used to treat skin infections such as athlete's foot and jock itch. Consumers buy it for its effectiveness in combating fungal infections.

Why This Is Dangerous

cGMP deviations can lead to manufacturing processes that fail to ensure the safety, quality, or efficacy of the product. This can result in a product that may not perform as expected or could pose health risks.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

This recall requires consumers to stop using the product and consult healthcare providers, potentially causing inconvenience and concern about health safety.

Practical Guidance

How to identify if yours is affected

  1. Check the packaging for the lot number A472418.
  2. Verify if you purchased the product after January 2025.
  3. Look for the product weight of 5 oz. (142 g) on the tube.

Where to find product info

The lot number is typically printed on the bottom of the tube or on the packaging.

What timeline to expect

Expect to receive guidance and notification via letter within a few weeks.

If the manufacturer is unresponsive

  • Document all communication attempts with Trifecta Pharmaceuticals.
  • Reach out to the FDA for further assistance if necessary.
  • Consider filing a complaint with consumer protection agencies.

How to prevent similar issues

  • Look for FDA approval or certification when purchasing medications.
  • Check for clear labeling on manufacturing standards.
  • Be cautious of products with vague descriptions or lack of safety information.

Documentation advice

Keep a record of your purchase receipt, any correspondence regarding the recall, and photographs of the product.

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Product Details

The recall involves Globe Clotrimazole Cream USP, 1% antifungal cream, packaged in 5 oz. (142 g) tubes. The affected lot number is A472418. The product was distributed nationwide in the USA.

Key Facts

  • Recalled product: Globe Clotrimazole Cream USP, 1%
  • Recall date: October 31, 2025
  • Quantity recalled: 14,700 bottles
  • Affected lot: A472418
  • Distribution: USA nationwide

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 TypeAntifungal Cream
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot #: A472418
UPC Codes
69396-087
69396-087-01
69396-087-55
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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