Timolol Maleate Ophthalmic Solution USP — Class II drug recall D-0114-2025
Ongoing recall by FDC Limited, reported 2024-12-18, distributed in NJ. Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the no
| Recall number | D-0114-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | FDC Limited, Aurangabad, Maharashtra State, India |
| Recall initiated | 2024-12-05 |
| Classified | 2024-12-06 |
| Reported by FDA | 2024-12-18 |
| Distributed | NJ |
| Quantity | 5,184 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 | 083I006 |
| Expiration dates | 2025-08-31 |
Product
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
Reason for recall
Defective Container: 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-0114-2025. 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.