HIGH

Trifecta Pharmaceuticals Recalls Clotrimazole Cream for cGMP Violations

Trifecta Pharmaceuticals USA recalled 12,150 bottles of Globe Clotrimazole Cream on October 31, 2025. The recall stems from deviations in current Good Manufacturing Practices (cGMP). Consumers should stop using the cream immediately and contact their healthcare providers.

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

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

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About This Product

Globe Clotrimazole Cream is a topical antifungal medication commonly used to treat skin infections such as athlete's foot and ringworm. Consumers buy it for its effectiveness in relieving itching and irritation caused by fungal infections.

Why This Is Dangerous

cGMP deviations indicate that the manufacturing process may not meet safety and quality standards, potentially leading to contamination or reduced effectiveness of the cream.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face health risks if they continue to use the affected product. The recall may cause inconvenience as users seek alternative treatments.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on your cream. The affected lot is A472408.
  2. Examine the packaging for the product's name and details.
  3. Verify that the product was purchased during the specified distribution period.

Where to find product info

The lot number can typically be found on the tube or box of the cream packaging.

What timeline to expect

Expect a refund to be processed within 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Document your communications with Blossom Pharmaceuticals.
  • Contact the FDA for additional assistance if the company is unresponsive.

How to prevent similar issues

  • Look for products with clear labeling indicating compliance with cGMP standards.
  • Check for certifications from regulatory agencies when purchasing medications.
  • Avoid purchasing products from unverified sources.

Documentation advice

Keep a copy of your purchase receipt and any correspondence with the company regarding the recall.

Product Details

The recalled product is Globe Clotrimazole Cream, USP, 1%, with a net weight of 1 oz (28.4g). The affected lot number is A472408. The cream was distributed nationwide in the USA.

Key Facts

  • Recall Date: October 31, 2025
  • Quantity: 12,150 bottles
  • Hazard: cGMP deviations
  • Classification: Class II
  • 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
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot #: A472408
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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