Is there a recall on Refresh PM lubricant eye ointment? A Comprehensive Guide to the 2024 Event

October 9, 2025 •

4 min read

In September 2024, a Class II recall was issued for several lots of Refresh PM lubricant eye ointment by its manufacturer, AbbVie (Allergan), addressing consumer concerns like 'Is there a recall on Refresh PM lubricant eye ointment?'. The recall was prompted by sterility concerns due to compromised tube seals, affecting over 3 million tubes across several countries.

Quick Summary

A recall for specific lots of Refresh PM lubricant eye ointment was initiated in September 2024 by AbbVie (Allergan) due to potential contamination from tube seal breaches. The FDA designated it a Class II recall, affecting millions of tubes distributed internationally and spanning multiple expiration dates.

Key Points

Recall Confirmed: A Class II recall was issued in September 2024 for specific lots of Refresh PM lubricant eye ointment due to potential sterility issues.
Reason for Recall: The recall was caused by breaches in the tube seals, which could lead to product leakage and microbial contamination.
Affected Lots: The recall involved millions of tubes with expiration dates ranging from 2024 to 2027; consumers must check their specific lot number.
Action for Consumers: If you have an affected product, stop using it immediately, dispose of it properly, and consider seeking a refund from the retailer.
Patient Safety: There was a potential risk of eye infection from using the recalled ointment, so users experiencing symptoms like pain or redness should contact a healthcare professional.
Manufacturer Information: The voluntary recall was initiated by AbbVie (Allergan), and resources are available on manufacturer and FDA websites.

Details of the Refresh PM Recall (September 2024)

In September 2024, the manufacturer AbbVie (Allergan) voluntarily initiated a recall for numerous lots of Refresh PM lubricant eye ointment, along with Refresh Lacri-Lube. The U.S. Food and Drug Administration (FDA) classified this as a Class II recall. This classification indicates that the use of the product may cause temporary or medically reversible adverse health consequences, though the possibility of serious harm is remote.

The primary reason for the recall was a breach in the tube seals, which compromised the sterility of the product and raised the risk of microbial contamination. Although the FDA did not report any adverse events associated with these specific products at the time of the recall, the potential for eye infections due to compromised sterility was significant.

Which lots were affected?

The recall impacted a large number of lots with expiration dates spanning from late 2024 through 2027. Consumers were advised to check their product’s lot number and expiration date, as even a non-leaking tube could be affected by the seal breach.

Recalled Lots of Refresh PM (3.5g tube, select examples):

T4534, T4535, T4591, T4592 (Exp. 12/24)
T4660, T4661, T4696, T4697, T4709, T4772, T4773 (Exp. 1/25)
387392, 387393, 387394, T4844, T4845 (Exp. 2/25)
391688, 391734 (Exp. 10/25)
392616, 392620 (Exp. 12/25)
392987, 393560 (Exp. 1/26)
409121, 409142 (Exp. 5/27)

Potential Risks and Symptoms

The primary danger associated with the recalled eye ointment is the risk of a potential eye infection. Eye ointments are intended to be sterile, and a compromised seal can allow contaminants to enter the product. While no adverse events were reported for the Refresh PM recall specifically, consumers should be aware of potential symptoms of an eye infection, including:

Eye pain
Redness
Changes in vision or blurred vision
Swelling of the eye or eyelids
Discharge from the eye
Increased sensitivity to light

If you experience any of these symptoms, you should stop using the product immediately and contact a healthcare professional.

How to Check and What to Do

Stop use immediately: If you have Refresh PM lubricant eye ointment, check the lot number and expiration date on the package. Even if your tube appears to be sealed and is not leaking, it is best to stop using any affected lot.
Verify your product: Compare your lot number and expiration date against the official lists provided by the manufacturer or the FDA. Your pharmacist can also help you confirm if your product is part of the recall.
Return the product: Contact the retailer where you purchased the ointment for information on returns and refunds. Many retailers, like Wegmans, offered refunds for affected products.
Consider alternatives: Talk to your pharmacist or eye care provider about switching to an alternative, unaffected lot of Refresh PM or another brand of lubricant eye ointment. Other products are available that were not part of the recall.

Comparison of Eye Ointments

Understanding the differences between lubricant eye ointments can help you make an informed choice. The following table compares Refresh PM (prior to the recall) with a general overview of alternatives.

Broader Context and Staying Informed

The September 2024 recall of Refresh PM and other eye ointments was not an isolated incident. Several other recalls of over-the-counter ophthalmic products occurred around the same period, often due to sterility concerns or manufacturing issues. This broader context underscores the importance of staying informed about medication and product safety.

To proactively check for recalls, consumers can use several resources:

FDA Website: Visit the FDA's "Recalls, Market Withdrawals, & Safety Alerts" page for up-to-date information on regulated products.
Recalls.gov: This is a "one-stop shop" for recalls from several federal agencies, including the FDA.
Retailer Websites: Many major retailers like Walgreens and Rite Aid post government and manufacturer recall notices on their websites.
Pharmacist: Your local pharmacist is a valuable resource who can verify if your medication is affected by a recall and recommend safe alternatives.

Conclusion

In conclusion, there was a significant recall of specific lots of Refresh PM lubricant eye ointment in September 2024 due to a potential sterility issue caused by faulty tube seals. This Class II recall, while not associated with reported adverse events at the time, posed a risk of eye infections. Consumers with affected products were advised to stop using them, check their lot numbers, and seek guidance from their pharmacist or healthcare provider. This event serves as a crucial reminder for all consumers to remain vigilant about product safety, particularly with over-the-counter medications, and to utilize available resources like the FDA website to stay informed about recalls and ensure personal safety.

For more detailed information on FDA drug recalls, please visit the official FDA Enforcement Reports page: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports.

Frequently Asked Questions

Yes, a Class II recall was issued for several lots of Refresh PM lubricant eye ointment in September 2024 by the manufacturer, AbbVie (Allergan).

The recall was due to a breach in the tube seals of the affected products, which compromised their sterility and posed a risk of potential contamination.

The FDA's Class II recall designation means that use of the product may cause temporary or medically reversible adverse health effects, with a remote possibility of serious harm.

You can check the lot number and expiration date printed on the tube and packaging. Compare this information with the official recall lists found on the FDA's website or other reliable sources like GoodRx.

Immediately stop using the product. You can contact the retailer for a refund or replacement and report any adverse effects to your healthcare provider or the FDA's MedWatch program.

Even if you do not have symptoms, it is recommended to stop using the affected product. If you have any concerns or experience delayed symptoms like redness or pain, contact an eye care professional.

Yes, lots of Refresh PM that are not on the recall list are safe to use. If you are unsure, consult your pharmacist for guidance or choose an alternative.