Official recall notice
FDA DrugClass IINotable
Fosfomycin Tromethamine Granules Recall (Oct 2026) – Cipla USA
Product: Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67.
- Recall date
- 2026-10-14
- Brand
- Cipla USA, Inc.
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
Failed Impurities/Degradation Specifications
Product description
Failed Impurities/Degradation Specifications
Affected products
Lot#: 5KA0405, Exp 12/31/2026.