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.
What this means for you
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
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.
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