Timolol Maleate Ophthalmic Solution USP — Class II drug recall D-0632-2024
Ongoing recall by FDC Limited, reported 2024-08-21, distributed nationwide. Defective container; yellow colored spike from cap lodged in the nozzle
| Recall number | D-0632-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | FDC Limited, Aurangabad, Maharashtra State, India |
| Recall initiated | 2024-07-18 |
| Classified | 2024-08-13 |
| Reported by FDA | 2024-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 362,544 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 |
| Lot numbers | 083J022 |
Product
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, [NDC 64980-514-05].
Reason for recall
Defective container; yellow colored spike from cap lodged in the nozzle
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-0632-2024. 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.