Loteprednol Etabonate recalls
The FDA has published 2 recalls involving Loteprednol Etabonate since 2019. The latest was reported on 26 Jul 2023. Most were for potency & assay. SUN Pharmaceutical Industries 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 recalls2since 2019
Last 12 months0reported
Class I00% of total
Ongoing0latest 26 Jul 2023
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 0 0%Class III 2 100%
Why loteprednol etabonate is recalled
Companies
Brands
By year
All loteprednol etabonate recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%) recalledLoteprednol Etabonate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile recalledLotemax | Bausch & Lomb | Potency & Assay | Nationwide |
Should you stop taking Loteprednol Etabonate?
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.