Is there a recall on timolol maleate eye drops?

Several recalls for timolol maleate ophthalmic solutions have been issued in recent years, including multiple notices in 2024 and 2025 by FDC Limited and its distributor Rising Pharmaceuticals. These recalls primarily stemmed from issues with defective product containers, highlighting the need for patients to be vigilant about medication safety.

Quick Summary

Recent FDA enforcement reports detail several recalls for timolol maleate ophthalmic solution, mostly initiated by FDC Limited due to defective container nozzles. Past issues have involved stability concerns with products from Apotex and contamination with Thea Pharmaceuticals. Patients should check official recall lists for affected lot numbers.

Key Points

• Recent Recalls Confirmed: Yes, there have been several recent recalls for timolol maleate ophthalmic solutions, notably by FDC Limited/Rising Pharmaceuticals in 2024 and 2025.

• Reason for Recent Recalls: The most common reason for recent recalls has been a defective container issue, where a cap component can block the nozzle and prevent the drops from being dispensed.

• Check Your Lot Numbers: Patients should check their eye drop bottles for the specific lot numbers identified in FDA alerts to confirm if their medication is affected.

• Contact Your Pharmacy and Physician: If your product is recalled, stop using it immediately and contact your pharmacist and doctor for a replacement and guidance on your glaucoma treatment plan.

• Risk Classification: The FDA classified the container defect recalls as Class II, indicating that while immediate harm is unlikely, it could cause temporary adverse health consequences.

• Practice General Eye Drop Safety: Regardless of recalls, always follow proper hygiene when using eye drops by washing hands and avoiding contact between the dropper tip and your eye or other surfaces.

Recent Recalls on Timolol Maleate Ophthalmic Solution

The most significant and recent recalls regarding timolol maleate eye drops involve products manufactured by FDC Limited and distributed by Rising Pharmaceuticals. Multiple batches were recalled throughout 2024 and extended into 2025 due to a consistent manufacturing defect related to the product's container. In these cases, a spike from the cap could become lodged in the nozzle, preventing the user from dispensing the solution.

FDC Limited / Rising Pharmaceuticals Recalls (2024-2025)

• July 2024: FDC Limited voluntarily recalled several lots of timolol maleate ophthalmic solution, 0.5%, in 5-mL bottles due to the defective container issue. The recall was designated as a Class II by the FDA in August 2024, indicating potential for temporary or medically reversible adverse health consequences.
• January 2025: A new recall was initiated by FDC Limited for additional lots of timolol maleate ophthalmic solution, again citing defective containers. This recall also received a Class II classification from the FDA, signifying a remote possibility of serious harm.
• May 2025: The FDA announced another nationwide recall involving additional lots of Timolol Maleate Ophthalmic Solution distributed by Rising Pharmaceuticals, specifically due to the defective cap and nozzle issue.

How to Identify a Recalled Product

To determine if your timolol maleate eye drops are affected by a recall, you must check the lot number and expiration date on the packaging. These details are usually printed on the bottle and the carton. If you have any of the specific lot numbers below, you should contact your pharmacist or physician immediately for guidance.

• Rising Pharmaceuticals (2024 Recall): Affected lot numbers for timolol maleate ophthalmic solution 0.5%, 5-mL bottles (NDC 64980-514-05) included 083H009 (Exp. 7/25), 083J022 (Exp. 9/25), and 083L046 (Exp. 11/25).
• Rising Pharmaceuticals (2025 Recalls): Additional affected lots for timolol maleate ophthalmic solution 0.5% have been identified, including those distributed in 5-mL and 10-mL bottles with expiration dates throughout 2025.

Understanding Reasons for Drug Recalls

Drug recalls are initiated for various reasons, with potential patient harm being the primary concern. Timolol maleate eye drops have faced recalls for a few different reasons over the years, not just container defects.

Previous Recalls on Timolol and Ophthalmic Solutions

1. Thea Pharmaceuticals (2024): One lot of Betimol (timolol ophthalmic solution) 0.5%, 15ml was recalled in March 2024 due to a potential quality defect that could compromise the container closure and potentially expose patients to bacterial contamination.
2. Apotex Corp (2023): Over 22,000 bottles of timolol maleate ophthalmic solution were recalled due to stability issues. Samples failed to meet specifications for weight loss, which could affect the product's concentration and effectiveness over time.
3. General Eye Drop Recalls (Ongoing): The FDA has issued multiple warnings and recalls for various over-the-counter and prescription eye drops in recent years, often due to sterility concerns and insanitary manufacturing conditions found during inspections. This highlights the ongoing risks associated with complex pharmaceutical supply chains.

Why Recalls Are Important

Recalls are a critical safety measure. Even seemingly minor issues, such as a defective container, can affect a product's sterility, dose delivery, or stability, posing risks to patient health, particularly for ophthalmic solutions where the risk of infection is a major concern. The FDA classifies recalls based on the potential for harm, guiding patients and healthcare providers on the appropriate response.

Timolol Maleate Recalls: Key Differences

Recall Incident	Manufacturer/Distributor	Date	Primary Reason	FDA Classification	Potential Risk	How to Identify
Container Defect	FDC Limited / Rising Pharmaceuticals	2024 & 2025	Defective bottle nozzle preventing solution delivery.	Class II	Temporary or medically reversible adverse consequences; remote possibility of serious harm.	Check lot number and expiration date on label against official FDA alerts.
Contamination Risk	Thea Pharmaceuticals	March 2024	Potential quality defect affecting container closure, leading to bacterial contamination risk.	N/A (Voluntary)	Exposure to bacterial contamination.	Check lot number against recall notice for Betimol (timolol).
Stability Issue	Apotex Corp	December 2022	Samples failed stability tests for weight loss, affecting drug concentration.	Class III	Not likely to cause adverse health consequences.	Check lot number against recall notice for Apotex timolol.

What to Do If Your Eye Drops Are Recalled

If you discover that your timolol maleate eye drops are part of a recall, take the following steps immediately:

1. Do not use the product: Immediately stop using the affected eye drops. Using a recalled ophthalmic solution could potentially harm your eyes.
2. Contact your pharmacy: Your pharmacy can confirm if your prescription is among the recalled lots and arrange for a replacement. They may also provide instructions for returning the recalled product.
3. Consult your physician: Talk to your doctor about the recall and determine the best course of action for your treatment. A lapse in glaucoma medication could be harmful, so a plan for switching to an unaffected batch or an alternative treatment is necessary.
4. Safely dispose of the product: Follow the disposal instructions from your pharmacy or physician. Never pour medication down the drain or flush it down the toilet unless specifically instructed to do so.
5. Report adverse effects: If you believe you have experienced a side effect or an adverse reaction from a recalled product, report it to your doctor and to the FDA's MedWatch program. More information can be found on the FDA website.

General Best Practices for Eye Drop Safety

Recalls serve as an important reminder to practice good hygiene and safety when using any ophthalmic product. A small mistake can lead to bacterial contamination and serious eye infections.

• Wash your hands: Always wash your hands thoroughly with soap and water before handling eye drops.
• Do not touch the tip: Prevent the dropper tip from touching your eye, eyelid, or any other surface to avoid contaminating the solution.
• Store properly: Keep eye drops in a cool, dry place away from direct sunlight, and follow any specific storage instructions on the label.
• Discard after use: If using single-use containers (like Timoptic in Ocudose), discard the container immediately after use. Do not save leftover medicine.
• Check for damage: Before each use, inspect the container for any damage, such as cracks, leaks, or a detached nozzle.

Conclusion

The answer to "Is there a recall on timolol maleate eye drops?" is yes, there have been multiple recent recalls, primarily due to defective containers from the manufacturer FDC Limited. While the potential for serious harm was classified as remote for the container defects, it underscores the importance of staying informed about medication alerts. Patients on this medication should remain diligent in checking their product lots against official FDA announcements and always practice proper eye drop hygiene to ensure their health and safety. The FDA's website is a valuable resource for checking current and past recalls.

For the latest official information, refer to the FDA Drug Recalls, Shortages and Safety Alerts page.

Frequently Asked Questions

Which company recalled timolol maleate eye drops in 2025?

FDC Limited, the manufacturer, issued a voluntary recall for several lots of timolol maleate ophthalmic solution, which were distributed by Rising Pharmaceuticals Inc. in 2025.

What was the reason for the most recent timolol eye drop recall?

The most recent recalls were due to a defective container issue where a spike from the cap could become lodged in the bottle's nozzle, preventing the solution from being dispensed.

How can I check if my prescription timolol is recalled?

You need to check the lot number and expiration date on your bottle and carton against the FDA's official recall announcements. If your lot matches, stop using the product immediately.

What should I do if my timolol eye drops are affected by a recall?

You should stop using the drops and contact your pharmacist or prescribing doctor for a replacement. They will guide you on how to return or dispose of the recalled product safely.

Is the risk of harm high with the recent timolol recall?

The recent FDC/Rising Pharmaceuticals recalls were classified by the FDA as Class II, meaning the risk is associated with temporary or medically reversible adverse health consequences, with a remote possibility of serious harm.

Have there been other recalls for timolol maleate eye drops recently?

Yes, other recalls have occurred. For example, Thea Pharmaceuticals recalled a lot of its timolol product (Betimol) in March 2024 due to potential contamination risk. Apotex also recalled timolol in 2023 for stability concerns.

Where can I find a list of all current FDA eye drop recalls?

You can find a comprehensive and updated list of all eye drop recalls on the FDA's official website under the 'Drug Recalls, Shortages and Safety Alerts' section.

Is it safe to continue using my timolol eye drops if they are not on the recall list?

Yes, if your specific lot number is not on any official recall list, it is considered safe to continue using the medication as prescribed. However, always practice proper hygiene to prevent contamination.