FDA-Drug2026-10-14Class IICHEMICAL
Cipla Fosfomycin Tromethamine Granules recalled for failed impurity specifications
What this means
Cipla USA is recalling one lot of Fosfomycin Tromethamine Granules for Oral Solution due to failed quality testing for impurities and degradation. The affected lot (5KA0405, expiring 12/31/2026) was distributed nationwide. No injuries have been reported.
- Check if you have lot #5KA0405 of Fosfomycin Tromethamine Granules (expiring 12/31/2026).
- Contact your pharmacy or healthcare provider if you have this lot.
- Do not use the medication; return it to your pharmacy for replacement or guidance.
The agency's original wording
Hazard
Failed Impurities/Degradation Specifications
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide.
Affected count
N/A
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0014-2027Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.