Clotrimazole cream, 1 ounce size, recalled over good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 12150 bottles of Globe Clotrimazole Cream over current good manufacturing practice deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: Scored 2 because the record cites current good manufacturing practice deviations with no stated product defect or reported harm.
Plain-English summary
Globe Clotrimazole Cream, USP, 1%, net weight 1 oz (28.4 g), made in India, NDC 69396-087-01, distributed by Trifecta Pharmaceuticals USA of Ft. Lauderdale, Florida, is being recalled.
The reason given in the enforcement record is cGMP deviations.
The recall covers 12150 bottles from lot A472408. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
The record cites manufacturing practice deviations without describing a specific product defect, and states no injuries. Customers should follow the firm's instructions.
The recalled product
- Product
- CLOTRIMAZOLE (CLOTRIMAZOLE)
- Brand
- CLOTRIMAZOLE
- Manufacturer
- Blossom Pharmaceuticals
- Category
- Drug — Antifungal
- Affected units
- 12,150
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.
Part of a larger recall action
This product is one of 13 recalled by Blossom Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
Same brand · CLOTRIMAZOLE
- ModerateClotrimazole cream, 5 ounce size, recalled over good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateTaro Recalls Clotrimazole Cream Due to Unknown Impurity
FDA (Drugs) · 2020-12-23
Same manufacturer · Blossom Pharmaceuticals
See all →- ModerateWound hydrogel recalled over current good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateDynashield Skin Protectant, 16 ounce size, recalled over manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateWeCare zinc oxide ointment recalled over good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateLanashield Skin Barrier recalled over current good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
- ModerateNivagen zinc oxide ointment recalled over good manufacturing practice deviations
FDA (Drugs) · 2025-12-10
Same hazard · cgmp deviation
See all →- ModeratePritam International Recalls Brush Buddies Toothpaste Due to CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModeratePritam International Recalls evo Sensitive Anticavity Fluoride Toothpaste
FDA (Drugs) · 2026-10-28
- ModeratePritam International Recalls Brush Buddies Fluoride Toothpaste for CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModeratePritam International Recalls Brush Buddies Toothpaste Due to CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModeratePritam International Recalls My Little Pony Toothpaste for CGMP Deviations
FDA (Drugs) · 2026-10-28
Similar recalls
- ModerateProfarma Recalls 1% Clotrimazole Cream Due to Manufacturing Deviations
FDA (Drugs) · 2016-06-29
- ModerateWecare Enema recalled over current good manufacturing practice deviations
FDA (Devices) · 2025-12-10
- ModerateCura Hongos clotrimazole cream recalled over manufacturing practice deviations
FDA (Drugs) · 2026-06-24
- ModerateWecare Calasoothe recalled over current good manufacturing practice deviations
FDA (Devices) · 2025-12-10
- ModerateMed Pride clotrimazole antifungal cream recalled over manufacturing practice deviations
FDA (Drugs) · 2026-06-24
- ModerateLucky Super Soft athlete's foot cream recalled over manufacturing deviations
FDA (Drugs) · 2026-06-24