HIGH

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.

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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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.

The Hazard

The recall stems from deviations in current Good Manufacturing Practice (cGMP) regulations. These violations can lead to products that are not safe or effective, posing potential health risks.

Reported Incidents

Currently, there are no reported injuries or adverse effects linked to the use of this product. However, the potential for harm exists due to the manufacturing deficiencies.

What to Do

Consumers should stop using the product immediately. For further guidance, contact Blossom Pharmaceuticals or consult with a healthcare provider.

Contact Information

For inquiries regarding the recall, consumers can reach Trifecta Pharmaceuticals at their office located at 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, 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

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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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