Timolol Maleate Ophthalmic Solution USP — Class II drug recall D-0642-2024
Ongoing recall by FDC Limited, reported 2024-08-28, distributed nationwide. Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lod
| Recall number | D-0642-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | FDC Limited, Aurangabad, Maharashtra State, India |
| Recall initiated | 2024-08-12 |
| Classified | 2024-08-22 |
| Reported by FDA | 2024-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 176,784 bottles |
| 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 | 2025-08-31, 2025-10-31 |
Product
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
Reason for recall
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
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-0642-2024. 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.