Sterility problems are trending (escalating?) in eye drop manufacturing facilities worldwide
Between 2022 and 2026:
(as of 9/29/2026)
178 eye drops and 1 PF saline recalled
Since 2022, 178 over-the-counter eye drops have been recalled. Most people are not aware of this, since they usually only make the news if the recall is associated with well-known brand names, large quantities, and consumer-level recall notices.
So far in 2026 alone, 110 eye drops have been recalled. About 75% of these were generics made by KC Pharma in southern California. In terms of salines, as many of you know, Nutrifill was recalled in 2025. It was made at Asept Pak in New York.
20 manufacturing facilities received FDA Warning Letters
FDA regularly inspects eye drop manufacturing facilities, both domestic and foreign. When serious manufacturing violations are found, the company is given a detailed report and instructions to immediately address the issues and report back to FDA. This may be followed by correspondence between FDA and the company's lawyers. If the company fails to rectify the problems to the FDA's satisfaction, eventually the FDA issues a Warning Letter, which is posted publicly on the FDA's site.
Between 2022 and today, 20 different eye drop manufacturing facilities have received such Warning Letters, specifically citing sterility failiures. Two facilities (KC Pharma in the US, Excelvision in France) received such letters twice in just a few years.
Problems at home and abroad
The most famous eye drop recall involved products made in India - Ezricare, in 2023, due to multiple treatment-resistant Pseudomonas infections which led to several deaths and dozens of people losing their sight.
However, half of the facilities that have been the subject of FDA enforcement actions in the past 5 years are right here in the US.
No major Big 3 issues until now
Most recalls in 2022-2025 were generics, specialty products, and second-tier brands made by relatively small manufacturers (with minor exceptions, such as 1 lot of 1 Systane product a couple years ago). This changed abruptly in 2026 when a popular contract manufacturer in France (Excelvision) had to recall several products from many well known companies (Oasis, Thea, Scope, Alcon and Harrow). Since then, we've seen Rohto and Clear Eyes brands recalled, among others, and we saw a 2nd and larger round of KC Pharma generic & private label recalls.
Bausch & Lomb receives FDA Warning Letter
FDA cites multiple serious violations at Bausch & Lomb flagship Tampa manufacturing facility
Earlier this month, we received the bombshell news that Bausch & Lomb had received an FDA Warning Letter after a routine inspection and subsequent correspondence.
Bausch was cited for extensive procedural failures linked to product contamination risks. We obtained a copy of the Form 483 (inspection report) that led to the Warning Letter.
I will not get into the technical details here. I will just say I was shocked to find how similar some of the citations were to the Excelvision violations, including environmental monitoring failures, such as potential moisture-related issues, and failure to take proper action on consumer complaints after testing samples. I'm pleased that FDA is placing so much emphasis on complaint follow-ups, but disheartened that Bausch could have failed to this extent.
FDA redacted all product names from the 483 and the Warning Letter, as per usual. It is clear from the records of consumer complaints on the 483 that there have been adverse events and there have been issues with both bottles and tubes (i.e. drops and ointments). But according to DailyMed, this facility produces at least 70 different ophthalmic drugs - mostly prescription drugs, and mostly preserved. They are also a contract manufacturing facility for other brands. So we have no way to tie the citations to any particular drugs or drug classes (OTC or Rx).
A little more Bausch & Lomb context
As some of you know, I've been eyeing Bausch for some time now. Their Greenville, SC facility where several preservative-free eye drops are made received a failing "red" grade (Official Action Indicated) in its 2025 inspection. Their contract manufacturer where Scleralfil is made has received only yellow and red grades for more than 10 years.
Meanwhile, back home at the Dry Eye Shop
Our quandary
After 5 long years of recalls, we'd like to have some way to get ahead of things. There are often clear warning signs in industry. Can't we get ahead of this and pull products before people get hurt and recalls happen?
After all, failed inspections and FDA Warning Letters are so often either preceded or followed by recalls, and many of our customers are high risk for infections.
On the other hand, pulling products prematurely brings additional issues.
Take Muro 128 as an example. We can pull it from our shelves, but we have no idea what the probability is that Muro was one of the problem products, and we can't recommend an alternative because the generics on the market are either contract manufactured at the Bausch facility - or, honestly, someplace worse.
There are no good answers in this situation. So all we can really do is be transparent and wait for developments.
Our policy - for now:
1) We will not stop stocking products based on FDA Warning Letters or inspection reports until/unless the products are recalled by the manufacturer or are in some other way specifically identified by the FDA in public documents.
2) We will be 100% transparent about manufacturing safety information that comes to our attention , so that you can review it and discuss it with your doctor and make an informed decision.
In the current case, a link to this blog post will be added to each Bausch product that is made at a facility of concern.
Dear industry: Please clean up your act!
The entire sterile ophthalmic manufacturing community - not just the latest ones to get in trouble - needs to invest in safety standards that stand up to scrutiny. We're counting on you. Please don't disappoint.