FDA Drug recall D-0543-2025
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra,…
- FDA Drug
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra,… by Fdc, citing defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0543-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-05 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fdc |
| Distribution | US |
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
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Identifiers
| ndc | 64980-513-05 |
|---|---|
| ndc | 64980-513-01 |
| ndc | 64980-513-15 |
| ndc | 64980-514-05 |
| ndc | 64980-514-01 |
| ndc | 64980-514-15 |
| code_info | Lot#: 083L061, Exp.: 11/2025. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0543-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.