Loteprednol Etabonate Ophthalmic Suspension — Class III drug recall D-0924-2023
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2023-07-26, distributed nationwide. Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
| Recall number | D-0924-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2023-07-05 |
| Classified | 2023-07-17 |
| Reported by FDA | 2023-07-26 |
| Terminated | 2024-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 20,884 cartons |
| Reason classes | potency, specification failure |
| NDC | 62756-0232, 62756-0232-55, 62756-0232-56, 62756-0232-90 |
| Expiration dates | 2023-06, 2023-10, 2023-11, 2024-03, 2024-07, 2024-08 |
Product
Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.
Reason for recall
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0924-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.