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

FDA recall notice · announced October 14, 2026 · Cipla

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

Failed Impurities/Degradation Specifications

Notes

Distribution: USA Nationwide.
Lot/code information: Lot#: 5KA0405, Exp 12/31/2026.
Quantity: N/A
Status: Ongoing
Products in this recall event:
- 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 (D-0014-2027)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.