FDA Issues Recall for 3 Million Eye Drop Bottles Over Sterility Concerns
The U.S. Food and Drug Administration has disclosed a voluntary recall affecting more than 3 million eye drop bottles. The recall was announced in an enforcement report dated March 31, 2026. K.C. Pharmaceuticals of Pomona initiated the action.
Scope of the recall
Company officials cited a lack of assurance of sterility in manufacturing. The issue means the firm cannot guarantee the products were free of infection-causing microbes. The total recalled quantity is 3,111,072 bottles.
Products named
Several over-the-counter formulations are included. Notable examples are products labeled as Artificial Tears, Advanced Relief, and Redness Lubricant drops.
Retailers and distributors
- CVS Health
- Walgreens
- Rite Aid
- Kroger
- H-E-B
- Publix
- Meijer
- Harris Teeter
- Dollar General
- Circle K
- Cintas
- Cardinal Health (distributor)
- McKesson (distributor)
- Wholesale and store brands such as Leader and Equaline
Lot codes and expiration
Consumers should inspect lot numbers and expiry dates carefully. Most affected lots carry expiration dates into May or October 2026.
| Lot Prefix | Notes |
|---|---|
| AC | Included in recall |
| AR | Included in recall |
| LT | Included in recall |
| SU | Included in recall |
| RG | Included in recall |
| RL | Included in recall |
| SY | Included in recall |
| AT | Included in recall |
What consumers should do
Stop using any bottles that match the recalled lots. Set those products aside and avoid contact with the eyes.
If you develop eye pain, redness, or vision changes, seek medical attention promptly. Major retailers are expected to accept returns or exchanges for affected lots.
Outstanding questions
The FDA report did not state that contamination was detected. Regulators said only that sterility assurance was not met.
There is no formal manufacturer refund process detailed in the report. Consumers should check with retailers for return or exchange policies.
Filmogaz.com reviewed the FDA enforcement report published March 31, 2026. The report is the basis for this summary about the recall and sterility concerns involving 3 million eye drop bottles.
