Loteprednol Etabonate recalls

Loteprednol Etabonate products have been recalled 1 time, most recently on 26 Jul 2023. The recalling company is usually SUN Pharmaceutical Industries. The most common reason is potency & assay.

Total recalls1since 2023
Last 12 months0reported
Class I00% of total
Ongoing0latest 26 Jul 2023

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 0 0%Class III 1 100%

Why loteprednol etabonate is recalled

Product types

By year

All loteprednol etabonate recalls, newest first

1 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIILoteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%) recalledLoteprednol EtabonateSUN Pharmaceutical IndustriesPotency & AssayNationwide

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.