Refresh recalls: Separating drops from ointments
For consumers, navigating the landscape of medication recalls can be confusing, especially with the high volume of ophthalmic product recalls in recent years. It is important to distinguish between the different types of Refresh products that have been recalled, as they happened at different times for different reasons.
Refresh Relieva PF eye drops recall (2022)
In September 2022, the manufacturer Allergan recalled two specific lots of its Refresh Relieva PF 10 mL eye drops. The recall was initiated due to a potential risk of bacterial contamination. While the recall was conducted at the retail level, consumers were urged to stop using the affected drops immediately due to the possible risk of infection. The specific lot numbers affected were T0392 and T0843, with expiration dates in July and August 2022, respectively.
Refresh P.M. and Refresh Lacri-lube eye ointment recall (2024)
Separately, in September 2024, AbbVie (the parent company of Allergan) initiated a recall for millions of tubes of Refresh P.M. and Refresh Lacri-lube lubricant eye ointments. This recall was a Class II event, which indicates a situation where a product may cause a temporary health problem or pose only a slight threat of a serious health problem. The cause was identified as a breach in the tube seals, which could lead to potential contamination. While no adverse events were reported in connection with this specific incident, the company took action out of an abundance of caution. The recall applied to a large number of lots with expiration dates ranging from 2024 to 2027. The recall was primarily at the retail and healthcare professional level, with no direct consumer notification required.
The broader context of recent eye drop recalls
It is easy to get Refresh brand recalls confused with the more widely publicized eye drop recalls of 2023, which involved multiple brands and were linked to severe eye infections, vision loss, and even death. While those events brought increased scrutiny to the eye care product market, they involved different manufacturers and products. These high-profile recalls included:
- EzriCare Artificial Tears and Delsam Pharma's Artificial Tears: Recalled in early 2023 due to contamination with a rare, drug-resistant bacteria (Pseudomonas aeruginosa). This was one of the most severe recalls, with serious patient outcomes reported.
- Store-brand artificial tears: In October 2023, the FDA warned against using numerous store-brand lubricating drops sold by retailers like CVS, Rite Aid, Target, and Walmart. The recall was due to unsanitary manufacturing conditions found at the facility of manufacturer Kilitch Healthcare India.
- Systane Lubricant Eye Drops Ultra PF: In December 2024, Alcon voluntarily recalled a specific lot (10101) of these drops after fungal material was reported in a single-use vial.
This history underscores the importance of staying informed about product recalls and practicing good eye care hygiene.
How to check for recalled products
If you have any concerns about your eye drops, you can verify if a specific product or lot number has been recalled by visiting the FDA's website, which publishes enforcement reports and safety alerts. It is always best to check directly with the manufacturer or pharmacy of purchase for the most accurate information.
| Recall Event | Affected Products | Cause for Recall | Reported Adverse Events | How to Check | Status of Recall |
|---|---|---|---|---|---|
| Refresh Relieva PF (2022) | Specific lots of Refresh Relieva PF eye drops (T0392, T0843) | Potential bacterial contamination | Yes, prompted by infection fears | Check lot and expiration date | Terminated (specific lots) |
| Refresh Ointments (2024) | Many lots of Refresh P.M. & Lacri-lube ointments | Tube seal breach causing leakage and possible contamination | No adverse events reported at time of recall | Check lot number and expiration date | Ongoing (until complete) |
| EzriCare/Delsam (2023) | EzriCare Artificial Tears & Delsam Pharma products | Contamination with drug-resistant Pseudomonas aeruginosa | Multiple severe eye infections, vision loss, and deaths reported | Recall list available on FDA website | Terminated (all products) |
| Store Brands (2023) | Various brands (CVS, Rite Aid, Target, etc.) from Kilitch Healthcare | Unsanitary manufacturing conditions | Few reports of non-severe effects at time of recall | Check product against FDA warning list | Terminated (all products) |
What to do if you suspect a problem
- Stop use immediately: If you have an eye product that is part of a recall, or if you suspect it may be compromised, discontinue use at once.
- Seek medical attention: If you experience any symptoms of an eye infection, such as redness, pain, discharge, blurred vision, or sensitivity to light, contact an eye care professional immediately.
- Check lot numbers: Locate the lot number and expiration date on your packaging. Compare this to the official recall notices from the manufacturer or the FDA.
- Dispose properly: Follow recall instructions for proper disposal or return. Generally, medications can be disposed of via designated drop-off sites or by mixing them with an unpalatable substance like coffee grounds before discarding in a sealed bag.
Conclusion
While the entire Refresh product line has not been recalled, it is a fact that specific drops (Refresh Relieva PF in 2022) and ointments (Refresh P.M. and Refresh Lacri-lube in 2024) have been subject to recalls. These incidents are distinct from the more dangerous, widespread recalls involving other brands in 2023. For your eye safety, it is always recommended to check the FDA’s recalls page for the most up-to-date information and to seek medical advice if you experience any adverse symptoms. The integrity of eye care products is critical, and staying informed is the best way to ensure your eye health.
For more information on drug safety and recalls, consult the official FDA resources: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
