FDA Drug recall D-0632-2024
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 2024-08-21
On 2024-08-21 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; yellow colored spike from cap lodged in the nozzle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0632-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-18 |
| Published | 2024-08-21 |
| 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; yellow colored spike from cap lodged in the nozzle
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 Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25 |
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-0632-2024%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.