Class III · Low risk
Loteprednol Etabonate Ophthalmic Suspension
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Is Loteprednol recalled?
Not under an active recall.
Loteprednol was recalled 3 times in the past — all now closed. Most recent: Jul 5, 2023.
Most common reason: Wrong potency / content (1 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Loteprednol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Loteprednol recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
Lotemax Sm
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Lotemax (loteprednol etabonate ophthalmic gel 0.5%)
Failed Stability Specifications: Out of specification for viscosity.
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