Drug recall
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited…
FDA recall event 97219 · Class II · FDC Limited
Key facts
| Event ID | 97219 |
|---|---|
| Recall numbers | D-0543-2025 |
| Recalling firm | FDC Limited |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. |
| Initiation date | Jul 5, 2025 |
| Report date | Aug 6, 2025 |
| City | Aurangabad, Maharashtra State |
| Country | India |
| FEI number | 3003204330 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: