BRANMOOR
THURSDAY ยท 14 MAY 2026

FDA Recall D-0210-2026

Blossom Pharmaceuticals

Class II Ongoing 195 days on record

Moderate impact — Class II recall โ€” temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.

Lot / code: Lot #: A472408

Quantity: 12150 bottles

Reason for recall

cGMP deviations

Recall record

Recall number
D-0210-2026
Classification
Class II
Status
Ongoing
Voluntary or mandated
Voluntary: Firm initiated
Firm notification
Letter
Distribution
USA Nationwide
Recall initiated
2025-10-31
Classified by FDA Center
2025-12-02
FDA published
2025-12-10
Recalling firm
Blossom Pharmaceuticals

Drug identification

Brand name(s)
CLOTRIMAZOLE
Generic name(s)
CLOTRIMAZOLE
Manufacturer(s)
TRIFECTA PHARMACEUTICALS USA LLC
NDC(s)
69396-087
Route(s)
TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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