Clotrimazole Topical Cream Recalled for Manufacturing Practice Deviations
Blossom Pharmaceuticals is voluntarily recalling its Globe Clotrimazole Cream (1%) due to cGMP deviations during manufacturing. The recall affects Lot #A472408 distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary, firm-initiated Class II recall for cGMP deviations with no reported illnesses or injuries. Per the rubric, voluntary precautionary recalls without reported harm are scored as Moderate (2).
Plain-English summary
Globe Clotrimazole Cream, USP, 1% (28.4g bottles), distributed by Trifecta Pharmaceuticals USA, is being recalled due to cGMP (current Good Manufacturing Practices) deviations identified during manufacturing. The product was made in India and distributed nationwide in the USA.
The recall affects Lot #A472408 and involves 12,150 bottles. Blossom Pharmaceuticals, the manufacturing firm, initiated this voluntary recall on October 31, 2025, in response to manufacturing practice deviations.
Consumers who have purchased this product should contact Trifecta Pharmaceuticals USA or Blossom Pharmaceuticals with questions about the recall.
The recalled product
- Product
- CLOTRIMAZOLE (CLOTRIMAZOLE)
- Brand
- CLOTRIMAZOLE
- Manufacturer
- Blossom Pharmaceuticals
- Category
- Drug — Topical Antifungal
- Hazard
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: A472408
UPCs (1)
- 0094922042002
Distribution
Distributed nationwide across the United States.
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- ModerateClotrimazole Antifungal Cream Recalled for Manufacturing Compliance Issues
FDA (Drugs) · 2025-12-10
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