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.
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.