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Major Eye Drop Recall: Millions of Bottles Pulled From Shelves
Millions of bottles of popular over-the-counter eyedrops are being urgently recalled across the United States after a Food and Drug Administration (FDA) audit uncovered serious manufacturing flaws. The recall, affecting a wide range of artificial tears and lubricating eye solutions, has prompted warnings for consumers to immediately stop using the affected products.
The voluntary recall was initiated by BRS Analytical Service, LLC, and announced by AvKARE, the distributor, after the FDA audit found significant "Current Good Manufacturing Practice (CGMP) deviations." This means the products may not meet the FDA's strict quality standards for safety and sterility.
What's Being Recalled?
The recall involves five different eye care products, all distributed by AvKARE. These were shipped between May 26, 2023, and April 21, 2025, meaning some bottles may still be in use. While no specific illnesses have been directly linked to these particular products, the FDA classified the recall as Class II, meaning there's a "reasonable probability" that using them could cause serious health problems or even death. The FDA emphasizes the "lack of assurance of sterility" as a key concern.
- Artificial Tears Ophthalmic Solution (NDC# 50268-043-15) – 13,872 cases recalled
- Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC# 50268-066-15) – 1,610 cases recalled
- Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (NDC# 50268-068-15) – 32,876 cases recalled
- Lubricant Eye Drops Solution (Polyethylene Glycol 400 / Propylene Glycol) (NDC# 50268-126-15) – 13,104 cases recalled
- Polyvinyl Alcohol Ophthalmic Solution 1.4% (NDC# 50268-678-15) – 14,333 cases recalled
The total number of recalled cartons exceeds 1.8 million.
| Product Name | NDC Number | Cases Recalled |
|---|---|---|
| Artificial Tears Ophthalmic Solution | 50268-043-15 | 13,872 |
| Carboxymethylcellulose Sodium Ophthalmic Gel 1% | 50268-066-15 | 1,610 |
| Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% | 50268-068-15 | 32,876 |
| Lubricant Eye Drops Solution | 50268-126-15 | 13,104 |
| Polyvinyl Alcohol Ophthalmic Solution 1.4% | 50268-678-15 | 14,333 |
What Should You Do?
If you have any of these products, stop using them immediately. AvKARE is offering full refunds, including shipping costs. To get your refund, fill out the recall form on AvKARE's website and send it via fax or email. They will then send you instructions on how to return the product.
This isn't the first time eye drops have been recalled this year. Several previous recalls, some linked to serious infections and even death, highlight the critical importance of adhering to strict manufacturing standards.
A Pattern of Problems
This latest recall comes on the heels of several other concerning incidents involving eye care products. The FDA has been increasingly vigilant in recent months, issuing warnings about other contaminated or improperly made products, which sometimes lead to serious eye infections and vision loss. This underscores the importance of rigorous safety checks and the need for consumers to be aware of product recalls.
Conclusion
The large-scale recall of these popular eye drops serves as a stark reminder of the importance of rigorous manufacturing standards and FDA oversight in protecting public health. While the specific risks associated with this recall are still being investigated, the precautionary measure of removing the products from the market is vital. Consumers should check their medicine cabinets immediately and take action if they have any of the recalled products. Remember to consult your doctor if you experience any eye irritation or discomfort after using eye drops.
