Timolol Maleate Ophthalmic Solution — Class II drug recall D-0488-2024
Terminated recall by FDC Limited, reported 2024-05-15, distributed in NJ. Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from
| Recall number | D-0488-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | FDC Limited, Aurangabad, Maharashtra State, N/A, India |
| Recall initiated | 2024-04-25 |
| Classified | 2024-05-07 |
| Reported by FDA | 2024-05-15 |
| Terminated | 2026-05-21 |
| Distributed | NJ |
| Quantity | 382,104 units |
| Reason classes | packaging |
| NDC | 64980-0513, 64980-0513-01, 64980-0513-05, 64980-0513-15, 64980-0514, 64980-0514-01, 64980-0514-05, 64980-0514-15 |
| Expiration dates | 2025-06, 2025-07, 2025-08, 2025-09 |
Product
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
Reason for recall
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
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-0488-2024. 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.