In a disturbing development, the U.S. Food and Drug Administration’s recent audit has led to the voluntary recall of several over-the-counter eye products across the nation.
See the tweet below!
Concerned patriots may wonder about the safety of products on pharmacy shelves, and rightly so.
AvKARE initiated this recall due to “manufacturing deviations”, a term that should make consumers pause.
AvKARE, known for distributing pharmaceuticals, announced a voluntary recall following an FDA audit that uncovered manufacturing deviations.
This recall raises questions about quality control and potential risks associated with the use of these widely available eye drops.
Although the specific health risks are unknown, AvKARE itself acknowledged the possibility of risks due to “products of unacceptable quality.”
It’s a scenario that highlights the potential consequences of regulatory oversight failures.
The FDA’s audit uncovered issues affecting several over-the-counter eye products intended for dry and irritated eyes.
The recall impacts a range of products including 13,872 cases of Artificial Tears Ophthalmic Solution and 14,333 cases of Polyvinyl Alcohol Ophthalmic Solution, among others.
Consumers who have these products are urged to stop using them immediately.
The affected products were distributed from May 26, 2023, to April 21, 2025, with expiration dates from April 2025 to March 2027.
AvKARE’s recall campaign includes offering refunds and full credit, including shipping costs.
Consumers must fill out a recall form online, then fax or email it to receive a Return Authorization Form.
This effort is to ensure that the process of recalling is as efficient as possible for customers affected by these defects.
The recall, however, isn’t limited to AvKARE. BRS Analytical Service, LLC, following a similar FDA audit, issued a recall as well.
This broadens the scope of concern about what’s happening behind the scenes in the pharmaceutical industry, especially when unnoticed mishaps potentially endanger patient safety.
AvKARE has advised stores to inspect their inventory and discontinue the use of these products.
Despite the steps taken to rectify the situation, this serves as a stern reminder of the obligation companies have toward product safety.
Unfortunately, it’s the consumer who ultimately shoulders the burden of corporate negligence.
There’s a pertinent lesson in holding manufacturers and regulatory bodies accountable, ensuring no shortcuts in product safety evaluations that result in unsafe products hitting the shelves.
The FDA’s alert should prompt a broader review of how significant these manufacturing “deviations” are and reinforce the message that quality should never be compromised.
RECALL 🚨 Several over-the-counter eye products used to treat dry and irritated eyes have been voluntarily recalled following an audit by the U.S. Food and Drug Administration.https://t.co/8fWqwhZ0r2
— Good Morning America (@GMA) May 12, 2025
