Cipla Usa, Inc.: Fosfomycin Tromethamine Granules For Oral Solution, (equivalent To 3 Grams Of Fosfomycin), 1 Single-dose Sachet

Recalling firm
Cipla USA, Inc.
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.
Reason
Failed Impurities/Degradation Specifications
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-09-18
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
USA Nationwide.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/8d4880b6-a44e-4bb8-8fc9-997f0faa81ee