Recall archive / FDA drug enforcement

Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (... — FDA record D-0488-2024

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 25, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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
Reason: Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Classification: Class II
Recalling firm: FDC Limited
Quantity: 382,104 units
Agency-reported status: Terminated
Source record identifier: D-0488-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

New Jersey Only

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

New Jersey

Dates in the source

Report date: May 15, 2024
Recall initiation date: Apr 25, 2024
Center classification date: May 7, 2024
Termination date: May 21, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.