FDA Announces Recall of Eye Drops from Leading Brands Over Safety Concerns

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has announced a nationwide voluntary recall of 27 eye drop products, including those sold at CVS, Rite Aid, and Target, for potential safety reasons, including eye infection risk.¹

Announced on November 15, 2023, the eye drop products were voluntarily recalled by manufacturing company Kilitch Healthcare India Limited. The recalled eye drops included all lot numbers with expiration dates ranging from November 2023 to September 2025.

The recall followed a warning released by the FDA on October 27, 2023, recommending manufacturers recall all lots on October 25, 2023, after agency investigators found insanitary conditions and positive bacterial test results from environmental sampling of critical drug production areas.²

The recalled ophthalmic products were nationally distributed to wholesalers, retailers, and through the product distributor, Velocity Pharma LLC.¹ The FDA announcement noted the manufacturer has notified the distributor, which will inform wholesalers and retailers via mail of the voluntary recall and arrange for the return of all impacted products.

Kilitch Healthcare India Limited has not received any reports of adverse events related to this recall. However, the FDA has urged consumers, distributors, and retailers that have any product which is being recalled to case the distribution of the product. The agency also warned consumers to cease using the recalled eye drops and return any of the listed ophthalmic products back to the place of purchase.

Ophthalmic products intended for administration into the eye can pose an increased risk of harm to users, as they bypass many of the human body’s natural defenses. Individuals experiencing signs or symptoms of eye infection after drops use were encouraged by the FDA to talk to their healthcare provider or seek immediate medical care, as well as properly discard the product.

Healthcare professionals were urged to report any adverse events or quality problems with any medicine to the FDA’s MedWatch Adverse Event Reporting program.

For the full list of recalled ophthalmic products, view the below list:

CVS

• _{Lubricant Eye Drops 15 ML (Single/Twin Pack) (Carboxymethylcellulose Sodium Eye Drops 0.5% W/V)}
• _{Lubricant Gel Drops 15 ml (Single/Twin Pack) (Carboxymethylcellulose Sodium Eye Drops 1.0% W/V)}
• _{Multi Action Relief Drops 15 ml (Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops)}
• _{MILD MODERATE LUBRICATING EYE DROPS 15ML (Polyethylene glycol 400 0.4% w/v)}
• _{Lubricant Gel Drops 10 ml (Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops)}
• _{Lubricant Eye Drops 10 ml (Single/Twin Pack) (Propylene glycol Eye Drops 0.6% w/v)}

Leader

• _{Eye Irritation Relief 15 ml (Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops)}
• _{Dry Eye Relief 10 ml (Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops)}
• _{Dry Eye Relief 15 ml (Carboxymethylcellulose Sodium Eye Drops 1.0% W/V)}
• _{Lubricant Eye Drops 15 ML (Single/Twin Pack) (Carboxymethylcellulose Sodium Eye Drops 0.5% W/V)}
• _{Lubricant Eye Drops 10 ml (Propylene glycol Eye Drops 0.6% w/v)}

Rite Aid

• _{MULTI-ACTION RELIEF DROPS 15ML (Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops)}
• _{LUBRICATING GEL DROPS 10ML (Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops)}
• _{LUBRICANT EYE DROPS 10ML (TWIN PACK) (Propylene glycol Eye Drops 0.6% w/v)}
• _{LUBRICANT GEL DROPS 15 ML (Carboxymethylcellulose Sodium Eye Drops 1.0% W/V)}
• _{LUBRICANT EYE DROPS 15ML (TWIN PACK) (Carboxymethylcellulose Sodium Eye Drops 0.5% W/V)}

Rugby

• _{LUBRICATING TEARS EYE DROPS 15 ML(Dextran 70- 0.1% w/v, Glycerin 0.2% w/v, Hypromellose 0.3% w/v)}
• _{Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml (Polyvinyl alcohol Eye Drops 1.4% w/v)}

Target

• _{High Performance Lubricant Eye Drops 15 ml (Single/Twin Pack) (Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops)}
• _{DRY EYE RELIEF 15 ML (TWIN PACK) (Carboxymethylcellulose Sodium Eye Drops 0.5% W/V)}

Velocity

• _{LUBRICANT EYE DROP 10ML (TRIPLE PACK) (Propylene glycol Eye Drops 0.6% w/v)}

Walmart

• _{EQUATE HYDRATION PF LUBRICANT EYE DROPS 10ML (Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops)}

References

1. _{Affairs O of R. Kilitch Healthcare India Limited issues voluntary nationwide recall of various eye drops for potential safety reasons. U.S. Food and Drug Administration. November 15, 2023. Accessed November 16, 2023. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kilitch-healthcare-india-limited-issues-voluntary-nationwide-recall-various-eye-drops-potential.}
2. _{Iapoce C. FDA warns against eye drops from major brands due to infection risk. HCP Live. October 30, 2023. Accessed November 16, 2023. https://www.hcplive.com/view/fda-warns-against-eye-drops-major-brands-infection-risk.}