Medications & Supplements/Prescription Drugs

Timolol Maleate Ophthalmic Solution Recalled for Defective Container

Agency Publication Date: May 7, 2024

Summary

FDC Limited and Rising Pharmaceuticals, Inc. have recalled 382,104 units of Timolol Maleate Ophthalmic Solution (USP, 0.5%) because of a defect in the packaging. A yellow-colored spike from the cap can become lodged in the nozzle of the bottle, which was discovered after several customers reported the issue. The recall affects both 5mL and 15mL prescription eye drop bottles distributed in New Jersey.

Risk

The plastic spike lodged in the nozzle can prevent the medication from being dispensed correctly or may fall into the user's eye during application, potentially causing physical injury or interfering with the treatment of eye conditions.

What You Should Do

This recall involves Timolol Maleate Ophthalmic Solution, USP, 0.5%, sold in 5mL bottles (NDC 64980-514-05) and 15mL bottles (NDC 64980-514-15) distributed by Rising Pharmaceuticals, Inc.
Check your medication for the following lot numbers: for 5mL bottles, check for lots 083H008 (Exp. 07/2025), 083G003 (Exp. 06/2025), and 083J017 (Exp. 09/2025); for 15mL bottles, check for lot 083I013 (Exp. 08/2025).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Timolol Maleate Ophthalmic Solution, USP, 0.5% (5mL)

Variants: 5mL, 0.5%, Ophthalmic Solution

Lot Numbers:

083H008 (Exp. 07/2025)

083G003 (Exp. 06/2025)

083J017 (Exp. 09/2025)

NDC:

64980-514-05

Distributed by Rising Pharmaceuticals, Inc, NJ.

Product: Timolol Maleate Ophthalmic Solution, USP, 0.5% (15mL)

Variants: 15mL, 0.5%, Ophthalmic Solution

Lot Numbers:

083I013 (Exp. 08/2025)

NDC:

64980-514-15

Distributed by Rising Pharmaceuticals, Inc, NJ.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94466

Status: Resolved

Manufacturer: FDC Limited

Sold By: Rising Pharmaceuticals, Inc.; Pharmacies

Manufactured In: India

Units Affected: 382,104 units

Distributed To: New Jersey

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves Timolol Maleate Ophthalmic Solution, USP, 0.5%, sold in 5mL bottles (NDC 64980-514-05) and 15mL bottles (NDC 64980-514-15) distributed by Rising Pharmaceuticals, Inc.

Check your medication for the following lot numbers: for 5mL bottles, check for lots 083H008 (Exp. 07/2025), 083G003 (Exp. 06/2025), and 083J017 (Exp. 09/2025); for 15mL bottles, check for lot 083I013 (Exp. 08/2025).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Timolol Maleate Ophthalmic Solution, USP, 0.5% (5mL)

Variants: 5mL, 0.5%, Ophthalmic Solution

Lot Numbers:

083H008 (Exp. 07/2025)

083G003 (Exp. 06/2025)

083J017 (Exp. 09/2025)

NDC:

64980-514-05

Distributed by Rising Pharmaceuticals, Inc, NJ.

Product: Timolol Maleate Ophthalmic Solution, USP, 0.5% (15mL)

Variants: 15mL, 0.5%, Ophthalmic Solution

Lot Numbers:

083I013 (Exp. 08/2025)

NDC:

64980-514-15

Distributed by Rising Pharmaceuticals, Inc, NJ.