Check Your Eye Drops Now: More than 75,000 units of eye drops and artificial tears have been recalled across the United States in a significant FDA Class II recall. The recall, which began on April 23, 2025, affects products made by BRS Analytical Services, LLC and distributed by AvKARE. These eye care products were available on shelves and in medical facilities nationwide from May 26, 2023, through April 21, 2025.
The reason for the recall? An FDA audit revealed that the manufacturing facility had serious deviations from current Good Manufacturing Practices (cGMP), particularly regarding sterility assurance. In simpler terms, the FDA found problems in how the products were made that could put your eyes at risk.
Check Your Eye Drops Now
| Topic | Details |
|---|---|
| Recalled Units | Over 75,000 |
| Date of Recall | April 23, 2025 |
| Products Involved | 5 types of eye care solutions |
| Distributor | AvKARE |
| Manufacturer | BRS Analytical Services, LLC |
| Reason | Sterility concerns and cGMP violations |
| FDA Recall Class | Class II (FDA.gov) |
The 2025 nationwide recall of over 75,000 units of eye care products is a serious reminder of the importance of product safety and regulatory compliance. While the risk of severe injury is low, consumers and healthcare providers alike should take prompt action to remove affected products from circulation.
What Products Are Being Recalled?
The following eye care products are included in this nationwide recall:
- Artificial Tears Ophthalmic Solution (NDC 50268-043-15)
- Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC 50268-066-15)
- Carboxymethylcellulose Sodium Ophthalmic Solution (NDC 50268-068-15)
- Lubricant Eye Drops Solution (NDC 50268-126-15)
- Polyvinyl Alcohol Ophthalmic Solution (NDC 50268-678-15)
These products were distributed to retail pharmacies, clinics, hospitals, and online outlets across the country. For complete details on lot numbers and expiration dates, visit the official FDA Recall Database.
Why This Matters: The Dangers of Contaminated Eye Drops
Even though this is a Class II recall (which means the health risk is not life-threatening), it is still serious. Contaminated or improperly manufactured eye drops can cause:
- Eye infections
- Vision damage
- Burning or stinging sensations
- Redness, swelling, or discharge
In severe cases, such conditions could lead to long-term vision problems if not treated promptly.
What You Should Do Immediately
If you or your patients use any of the listed products, follow these steps:
1. Stop Using the Product
Discontinue use of any affected eye drops immediately, even if you haven’t experienced symptoms.
2. Check Product Labels
Look at the NDC code and expiration date on the product packaging. Compare it with the list provided on the FDA’s recall notice.
3. Contact AvKARE for a Return or Refund
You can return affected products to AvKARE. Contact their customer service for instructions on how to obtain a replacement or refund.
4. Monitor for Symptoms
If you notice eye discomfort, redness, blurred vision, or any unusual symptoms, contact a healthcare provider immediately.
5. Report Problems to the FDA
You can report adverse events to the MedWatch Adverse Event Reporting System.
Understanding FDA Recall Classes
Here’s what a Class II recall means:
So, while this isn’t an emergency, it’s still important to take action to protect your health.
How Professionals and Consumers Can Stay Safe
Healthcare professionals should:
- Check their pharmacy inventories for recalled items
- Notify patients who may be using affected products
- Use only FDA-approved sterile solutions from verified manufacturers
Consumers should:
- Always check labels and NDC codes
- Sign up for FDA recall alerts at FDA.gov
- Buy eye drops only from reputable pharmacies or licensed healthcare providers
FAQs on Check Your Eye Drops Now
Q1: Are these eye drops safe to use if I haven’t had any symptoms?
A: No. Even without symptoms, the sterility of these products cannot be guaranteed. Stop using them immediately.
Q2: How can I tell if my eye drops are part of the recall?
A: Check the NDC number on the bottle against the recall list. If it matches, it’s part of the recall.
Q3: Can I get a refund?
A: Yes. Contact AvKARE’s customer support for instructions on returns and refunds.
Q4: What if I already used the recalled product?
A: If you notice any unusual eye symptoms, see your doctor. Even if you’re symptom-free, report your usage to the FDA
