Fosfomycin Tromethamine recalls

The FDA has published 3 recalls involving Fosfomycin Tromethamine since 2023. The latest was reported on 14 Oct 2026. Most were for potency & assay. Ascend Laboratories has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls3since 2023
Last 12 months1reported
Class I00% of total
Ongoing2latest 14 Oct 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 2 67%Class III 1 33%

Why fosfomycin tromethamine is recalled

By year

Ongoing fosfomycin tromethamine recalls

2 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIFosfomycin Tromethamine Granules for Oral Solution recalled by Cipla USAFosfomycin TromethamineCipla USAPotency & AssayNationwide
DrugCLASS IIFosfomycin Tromethamine Granules for Oral Solution recalledFosfomycin TromethamineAscend LaboratoriesPotency & AssayNationwide

All fosfomycin tromethamine recalls, newest first

3 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIFosfomycin Tromethamine Granules for Oral Solution recalled by Cipla USAFosfomycin TromethamineCipla USAPotency & AssayNationwide
DrugCLASS IIFosfomycin Tromethamine Granules for Oral Solution recalledFosfomycin TromethamineAscend LaboratoriesPotency & AssayNationwide
DrugCLASS IIIFosfomycin Tromethamine Granules recalled by Ascend LaboratoriesFosfomycin TromethamineAscend LaboratoriesPotency & AssayNationwide

Should you stop taking Fosfomycin Tromethamine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.