Food, drugs, devices › FDC Limited
Drug recall: Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aura
FDA enforcement event 96740 is a drug recall by FDC Limited of Aurangabad, Maharashtra State, N/A, initiated 18 Apr 2025 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 79% of the 322 drug enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. FDC Limited has 11 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
FDC Limited, Aurangabad, Maharashtra State, N/A, India.
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."
Distribution
"U.S. Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0403-2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01. | 60428 bottles | Class II | Ongoing | 14 May 2025 |
Context
Other enforcement events for FDC Limited
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S. Nationwide"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.