Fosfomycin Tromethamine recalls

Fosfomycin Tromethamine products have been recalled 3 times, most recently on 14 Oct 2026. The recalling company is usually Ascend Laboratories. The most common reason is potency & assay.

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

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 1 0

Severity split

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

Why fosfomycin tromethamine is recalled

Potency & Assay3100%

Companies

Ascend Laboratories267%
Cipla USA133%

By year

2026133%
2024133%
2023133%

Ongoing fosfomycin tromethamine recalls

2 active

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS II	Fosfomycin Tromethamine Granules for Oral Solution recalled by Cipla USAFosfomycin Tromethamine	Cipla USA	Potency & Assay	Nationwide
28 Feb 2024Drug	CLASS II	Fosfomycin Tromethamine Granules for Oral Solution recalledFosfomycin Tromethamine	Ascend Laboratories	Potency & Assay	Nationwide

All fosfomycin tromethamine recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS II	Fosfomycin Tromethamine Granules for Oral Solution recalled by Cipla USAFosfomycin Tromethamine	Cipla USA	Potency & Assay	Nationwide
28 Feb 2024Drug	CLASS II	Fosfomycin Tromethamine Granules for Oral Solution recalledFosfomycin Tromethamine	Ascend Laboratories	Potency & Assay	Nationwide
13 Sep 2023Drug	CLASS III	Fosfomycin Tromethamine Granules recalled by Ascend LaboratoriesFosfomycin Tromethamine	Ascend Laboratories	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.