In a concerning turn of events, the U.S. Food and Drug Administration (FDA) has announced the recall of another 27 eye drop products due to potential safety concerns. This latest recall follows a similar one issued just weeks ago, bringing the total number of recalled eye drops to over 50.
The affected products are manufactured by Kilitch Healthcare India Limited and include a variety of brands sold at major retailers such as CVS Health, Rite Aid, Target, and Walmart. The recall was initiated after FDA investigators found insanitary conditions at the manufacturing facility in India.
What You Need to Know
If you have purchased or used any of the recalled eye drops, it is important to stop using them immediately and return them to the store where you purchased them for a full refund. You should also contact your doctor if you have any concerns or have experienced any adverse reactions after using the products.
Here is a list of the recalled eye drops:
| Brand | Product Name | Lot Numbers | Expiration Dates |
|---|---|---|---|
| CVS Health | Artificial Tears Lubricant Eye Drops | NDC 69586-011-00, NDC 69586-010-00 | November 2023, September 2025 |
| Leader (Cardinal Health) | Artificial Tears Lubricant Eye Drops | NDC 51848-001-00 | November 2023 |
| Leader (Cardinal Health) | Artificial Tears Lubricant Eye Drops | NDC 51848-002-00 | September 2025 |
| Leader (Cardinal Health) | Artificial Tears Lubricant Eye Drops | NDC 51848-003-00 | November 2023 |
| Leader (Cardinal Health) | Artificial Tears Lubricant Eye Drops | NDC 51848-004-00 | September 2025 |
| Leader (Cardinal Health) | Artificial Tears Lubricant Eye Drops | NDC 51848-005-00 | November 2023 |
| Rugby (Cardinal Health) | Artificial Tears Lubricant Eye Drops | NDC 53192-001-00 | September 2025 |
| Rugby (Cardinal Health) | Artificial Tears Lubricant Eye Drops | NDC 53192-002-00 | September 2025 |
| Rite Aid | Artificial Tears Lubricant Eye Drops | NDC 69586-001-00 | November 2023 |
| Target | Artificial Tears Lubricant Eye Drops | NDC 69586-011-00 | November 2023 |
| Velocity Pharma | Artificial Tears Lubricant Eye Drops | NDC 69586-012-00 | November 2023 |
| Walmart | Artificial Tears Lubricant Eye Drops | NDC 69586-011-00 | November 2023 |
Potential Risks
The FDA has not received any reports of adverse events related to the recalled eye drops. However, there is a potential risk of eye infections or related harm due to the insanitary conditions at the manufacturing facility.
Symptoms of Eye Infections
If you experience any of the following symptoms after using eye drops, it is important to see your doctor right away:
- Redness, itching, or burning of the eyes
- Excessive tearing
- Blurred vision
- Pain in the eyes
- Discharge from the eyes
Prevention
To help prevent eye infections, it is important to follow these guidelines:
- Wash your hands thoroughly before using eye drops.
- Do not touch the tip of the eyedrop container to your eyes or any other surface.
- Replace the cap on the eyedrop container tightly after each use.
- Do not share eye drops with others.
- Dispose of expired eye drops properly.
FDA’s Ongoing Investigation
The FDA is continuing to investigate the manufacturing practices at Kilitch Healthcare India Limited and will take additional action as needed to protect public health.
Additional Information
For more information about the recall, please visit the FDA’s website: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye
You can also contact the FDA’s MedWatch program to report any adverse events related to the use of eye drops:
- Phone: 1-800-FDA-1088
- Fax: 1-800-FDA-01
