FDA has recalled several eye drop recalls in recent months due to various safety concerns. On November 15, 2023, there was a major recall of 27 eye drop products.
In this article, we are providing you complete information on FDA Eye Drops Recall. At the end, you will get a full list of all the recalled Eye Drop products with their brand names.
In January and February, two brands of eye drops were recalled due to their connection with a drug-resistant bacteria strain. This strain had caused at least four deaths and serious health issues in many others. Global Pharma recalled their eye drops in February due to a bacterial contamination.
Weeks later, two other types of eye drops were recalled because they posed a different kind of contamination risk. The FDA found unsanitary conditions at a manufacturing plant in October. As a result, 26 eye-care products were removed from shelves. In November, Amazon removed seven eye drops from its website. These products were not approved for sale in the United States according to the FDA warning.
FDA Eye Drop Recall 2023
Below are some of the most recent FDA Eye drop products recalls details :
| Date | Recall Details |
| 15/11/2023 | FDA warned citizens to immediately stop the use of 27 over the counter eye drop products. |
| 3/11/2023 | Cardinal Health Inc. voluntarily recalls all six Leader brand ophthalmic products. |
| 30/10/2023 | Walmart was asked to remove Equate Hydration PF Lubricant Eye Drop 10 mL from their online listing and shelves. |
| 27/10/2023 | FDA warned citizens to immediately stop the use of 26 over the counter eye drop products. |
FDA Complete Eye Drop Recall List 2023
Below is the list of All the recalled products with key details as provided by FDA. If you want, you can download the eye drop recall list pdf file too.
| Retailer/Brand | Product | Product Information | National Drug Code (NDC) |
| CVS Health | Lubricant Eye Drops 15 ml (single pack) | Carboxymethylcellulose Sodium 0.5% | 76168-702-15 |
| CVS Health | Lubricant Eye Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | 76168-702-30 |
| CVS Health | Lubricant Gel Drops 15 ml (single pack) | Carboxymethylcellulose Sodium 1% | 76168-704-15 |
| CVS Health | Lubricant Gel Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 1% | 76168-704-30 |
| CVS Health | Multi-Action Relief Drops 15 ml | Polyvinyl Alcohol 0.5%, Povidone 0.6%, and Tetrahydrozoline Hydrochloride 0.05% | 76168-706-15 |
| CVS Health | Lubricant Gel drops 10 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 76168-712-10 |
| CVS Health | Lubricant Eye Drops 10 ml (single pack) | Propylene Glycol 0.6% | 76168-714-10 |
| CVS Health | Lubricant Eye Drops 10 ml (twin pack) | Propylene Glycol 0.6% | 76168-714-20 |
| CVS Health | Mild Moderate Lubricating Eye Drops 15 ml (single pack) | Polyethylene Glycol 400 0.25% | 76168-711-15 |
| Leader (Cardinal Health) | Eye Irritation Relief 0.5 FL OZ (15 ml) | Polyvinyl Alcohol 0.5%, Povidone 0.6% and Tetrahydrozoline Hydrochloride 0.05% | 70000-0087-1 |
| Leader (Cardinal Health) | Dry Eye Relief 0.5 FL OZ (15 ml) | Carboxymethylcellulose Sodium 1% | 70000-0089-1 |
| Leader (Cardinal Health) | Lubricant Eye Drops 0.5 FL OZ (15 ml) (single) | Carboxymethylcellulose Sodium 0.5% | 70000-0090-1 |
| Leader (Cardinal Health) | Lubricant Eye Drops 0.5 FL OZ (15 ml) (twin pack) | Carboxymethylcellulose Sodium 0.5% | 70000-0090-2 (carton)70000-0090-1 (bottle) |
| Leader (Cardinal Health) | Dry Eye Relief 0.33 FL OZ (10 ml) | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 70000-0088-1 |
| Leader (Cardinal Health) | Lubricant Eye Drops 0.33 FL OZ (10 ml) | Polyethylene Glycol 0.6% | 70000-0587-1 |
| Rugby (Harvard Drug Group) | Lubricating Eye Drops 0.5 oz (15 ml) | Polyvinyl Alcohol 1.4% | 0536-1325-94 |
| Rugby (Harvard Drug Group) | Lubricating Tears Eye Drops 0.5 oz (15 ml) | Dextran/Hypromellose 0.1%/0.3% | 0536-1282-94 |
| Rite Aid | Lubricant Eye Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | 11822-9707-5 |
| Rite Aid | Lubricant Eye Drops 10 ml (twin pack) | Propylene Glycol 0.6% | 11822-4811-3 |
| Rite Aid | Gentle Lubricant Gel Eye Drops 15 ml | Hypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% | Not provided by the manufacturer |
| Rite Aid | Lubricant Gel Drops 15 ml | Carboxymethylcellulose Sodium 1% | 11822-9706-5 |
| Rite Aid | Lubricating Gel Drops 10 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 11822-4540-3 |
| Rite Aid | Multi-Action Relief Drops 15 ml | Polyvinyl Alcohol 0.5%, Povidone 0.6% and Tetrahydrozoline Hydrochloride 0.05% | 11822-2254-3 |
| Target | Up&Up Dry Eye Relief 15 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 76168-800-30 |
| Target | Up&Up High Performance Lubricant Eye Drops 15 ml (single pack) | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 11673-522-15 |
| Target | Up&Up High Performance Lubricant Eye Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | 11673-522-30 |
| Velocity Pharma LLC | Lubricant Eye Drop 10 ml (triple pack) | Propylene Glycol 0.6% | 76168-502-30 |
| Walmart | Equate Hydration PF Lubricant Eye Drop 10 mL | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 79903-168-01 |
What should you Do if you have recently used any of these Eye Drops?
If you have used any of the recalled eye drops and have symptoms of an eye infection, go to the doctor right away.
Symptoms: discharge from the eye (green, yellow, or clear), redness of the eye or eyelid, increased sensitivity to light, and eye pain or discomfort.
Safety Tips
- If you have any worries about the safety of your eye drops, get rid of them and buy a new, sealed bottle from a trusted company.
- Check the expiration date of your eye drops regularly.
- Don’t touch the tip of the bottle with your skin, eyelashes, or fingers to avoid contamination.
- If you have any issues with any of the recalled eye drops, you can file a report with the FDA online, by mail, or by fax.
How to Report
- Go to the FDA’s MedWatch Online Voluntary Reporting Form at online form page
- Select “Consumer/Patient” as the type of reporter.
- Complete all necessary fields, such as your personal details, product name, and a description of the problem you encountered.
- Click “Submit Report” to send your report to the FDA.
- To submit a report by mail or fax, you can download a printable Med Watch Reporting Form from the FDA’s website at the link:
- The form includes instructions for mailing or faxing your report to the FDA.
Quick Links
| Online Reporting Page | Click Here |
| Report by Mail or Fax | Click here |
| Recalled Eye Drops List PDF | Download Now |
Last Updated on November 17, 2023 by Vaibhav Tiwari