Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0924-2023·Announced 2023-07-26

Loteprednol Etabonate Eye Drops Recalled for Out-of-Specification Potency

Sun Pharmaceutical recalls Loteprednol Etabonate eye drops due to out-of-specification unit dose content in certain lots. Affected bottles may contain incorrect potency levels.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This recall is classified FDA Class III with no reported illnesses or injuries. The defect involves out-of-specification unit dose content—a manufacturing concern—but without evidence of actual harm, it falls under the voluntary precautionary category typical for Class III recalls.

Plain-English summary

Sun Pharmaceutical Industries Inc. is recalling Loteprednol Etabonate ophthalmic suspension 5 mg/mL (0.5%) due to out-of-specification (OOS) results observed for unit dose content. The recalled product is distributed nationwide.

The reason for the recall is that testing identified unit dose content outside the specified parameters. This means the actual amount of active ingredient in affected bottles may not match the labeled concentration of 5 mg/mL.

The recall affects 20,884 cartons distributed nationwide. Affected lot numbers include BAC0334A (exp. 06/2023), BAC0532A (exp. 11/2023), BAD0407A (exp. 08/2024), BAD0425A (exp. 08/2024), BAC0335A (exp. 06/2023), BAC0533A (exp. 10/2023), BAD0148A (exp. 03/2024), and BAD0320A (exp. 07/2024). The 10 mL bottles (NDC 62756-232-55) and 15 mL bottles (NDC 62756-232-56) are affected.

Patients currently using affected lots should contact their healthcare provider or pharmacist regarding this recall. Since this is a prescription medication, do not make any changes to your treatment without consulting a healthcare professional.

The recalled product

Product: LOTEPREDNOL ETABONATE (LOTEPREDNOL ETABONATE)
Brand: LOTEPREDNOL ETABONATE
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Category: Drug — Ophthalmic
Hazard: potency-defect
Affected units: 20,884

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

Lot#: a) BAC0334A
Exp 06/2023
BAC0532A
Exp 11/2023 BAD0407A
Exp 08/2024 BAD0425A
Exp 08/2024
b) BAC0335A
BAC0533A
Exp 10/2023
BAD0148A
Exp 03/2024
BAD0320A
Exp 07/2024

UPCs (1)

0362756232907

Distribution

Distributed nationwide across the United States.

Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC

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