Food, drugs, devices › FDC Limited
Drug recall: Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC
FDC Limited (Aurangabad, Maharashtra State, N/A) initiated this drug recall on 25 Apr 2024; FDA lists 1 product record under event 94466, classified Class II.
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. 71% of the 319 drug enforcement events initiated in 2024 carry the same class.
Status: Terminated, terminated 21 May 2026. 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: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers."
Distribution
"New Jersey Only"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0488-2024 | Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ | 382,104 units | Class II | Terminated | 15 May 2024 |
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: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers."
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: "New Jersey Only"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 May 2026. "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.