Navigating Eye Drop Safety: The Recall Status of Refresh Products
Given the widespread recalls of numerous over-the-counter (OTC) eye drops in 2023, 2024, and 2025, consumers are rightfully concerned about the safety of the products they use [1.4.3]. The primary question for many is whether Refresh, a popular brand manufactured by Allergan (an AbbVie company), has been subject to these sweeping recalls.
As of September 2025, there has not been a widespread, brand-level recall of the entire Refresh eye drop line for bacterial contamination similar to what was seen with brands like EzriCare or Delsam Pharma [1.3.7, 1.7.1]. However, specific lots of certain Refresh products have been voluntarily recalled. In September 2024, AbbVie (Allergan) initiated a Class II recall for numerous lots of Refresh P.M. and Refresh Lacri-Lube lubricant eye ointments [1.2.1, 1.2.2]. This recall, affecting over 3 million tubes, was due to a tube sealing issue that could compromise the product's sterility and lead to potential contamination [1.2.1, 1.2.3]. This was classified as a Class II recall, meaning use of the product could cause temporary or medically reversible adverse health consequences [1.2.2].
There was also a past, smaller recall for two lots of Refresh Relieva PF eye drops with expiration dates in 2022 due to contamination fears [1.4.1]. These specific, lot-based actions differ from the FDA's warnings and recalls for other brands, which were often due to unsanitary conditions at manufacturing facilities and confirmed findings of dangerous bacteria like Pseudomonas aeruginosa [1.4.4, 1.5.2].
The Dangers of Contaminated Eye Drops
The wave of eye drop recalls from 2023 to 2025 was largely triggered by contamination with harmful bacteria, most notably an extensively drug-resistant strain of Pseudomonas aeruginosa [1.7.3]. This bacterium, found in soil and water, can cause severe eye infections (like bacterial keratitis), which can lead to permanent vision loss, the need for surgical eye removal, and in some severe cases, death if the infection enters the bloodstream [1.5.2, 1.5.5]. The recalls of brands manufactured by Global Pharma Healthcare (EzriCare and Delsam Pharma) were linked to a multi-state outbreak with dozens of infections and multiple deaths [1.7.1, 1.7.2]. These incidents were often traced back to a "lack of assurance of sterility" and violations of Current Good Manufacturing Practice (CGMP) at production facilities [1.4.2, 1.7.5].
How to Ensure Your Eye Drops Are Safe
Staying informed is the best defense against using a potentially unsafe product. Here are concrete steps every consumer should take:
- Check the FDA Website: The FDA maintains a public database of all drug recalls, market withdrawals, and safety alerts [1.6.5]. You can search this database by product name (e.g., "Refresh") or the general term "eye drops" to find the latest information [1.6.1, 1.6.3].
- Examine Packaging: Do not use any eye drops if the tamper-evident seal is broken or the packaging appears damaged.
- Practice Good Hygiene: Always wash your hands thoroughly before administering eye drops. Never let the dropper tip touch your eye, eyelid, or any other surface to prevent contamination of the bottle's contents [1.5.2].
- Heed Expiration Dates: Discard any eye drops, opened or unopened, that have passed their expiration date [1.6.4].
Comparison of Recalled vs. Non-Recalled Brands
To understand the landscape, it's helpful to compare the situations.
| Feature | Recalled Brands (e.g., EzriCare, Delsam Pharma) | Refresh Brand (Allergan/AbbVie) |
|---|---|---|
| Recall Scope | Widespread brand recalls ordered by FDA or voluntarily due to major contamination [1.7.2]. | Specific, limited lot recalls for certain products (e.g., Refresh P.M.) [1.2.1]. Main product lines not part of the broad recalls [1.3.7]. |
| Stated Reason | Bacterial contamination (Pseudomonas aeruginosa), insanitary manufacturing conditions, lack of sterility assurance [1.4.4, 1.7.3]. | Packaging defects (tube seal issue) with potential for contamination; past limited lot recalls for contamination risk [1.2.1, 1.4.1]. |
| Manufacturer | Often smaller, less-known manufacturers like Global Pharma Healthcare or Kilitch Healthcare India [1.6.2, 1.7.2]. | A major pharmaceutical corporation (Allergan, an AbbVie company) [1.2.2]. |
| Reported Outcomes | Linked to a multi-state outbreak of severe infections, vision loss, and deaths [1.5.1, 1.5.5]. | No reports of adverse events were noted by the FDA in relation to the September 2024 ointment recall, though customer complaints prompted a past recall [1.2.3, 1.4.5]. |
Conclusion
While the main lines of Refresh eye drops have not been subject to the widespread bacterial contamination recalls that affected many other OTC brands, consumers must remain vigilant. Specific products like Refresh P.M. and Refresh Lacri-Lube have had significant lot recalls as recently as September 2024 due to packaging defects that pose a sterility risk [1.2.4]. It is crucial for users to verify the lot numbers of their products against the FDA's recall lists and practice safe usage habits. The distinction between a limited, voluntary recall by a major manufacturer for a packaging flaw and a broad recall for confirmed, dangerous contamination is significant, but both underscore the importance of product safety in ophthalmology.
For the most current official information, consumers should always consult the FDA's recall database.
