Cipla Usa, Inc.: Fosfomycin Tromethamine Granules For Oral Solution, (equivalent To 3 Grams Of Fosfomycin), 1 Single-dose Sachet
Recall Summary Cipla USA is recalling Fosfomycin Tromethamine Granules (a single-dose antibiotic medication for urinary tract infections) nationwide because the product failed quality tests for impurities and breakdown of the active ingredient. The recall affects all 50 states and Washington D.C., and applies to the specific product with NDC number 69097-579-67.
- 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/f41f7a3d-5a39-45da-bea7-c1bd61185075