Class I Recall for Dozens of OTC Eye Drops

Sterility concerns due to unsanitary manufacturing conditions have prompted the US Food and Drug Administration (FDA) to issue a Class I designation for a recall spanning 27 over-the-counter eye drops sold by various retailers throughout the United States. The recalls were published in the February 14, 2024, FDA Enforcement Report.

A Class I designation is the FDA’s most serious recall category and warns use of the recalled products could cause serious adverse health consequences or death. The recall includes all lots within expiry of the following products:

• Rugby brand Lubricating Tears Eye Drops 15 mL (dextran 70- 0.1% w/v, glycerin 0.2% w/v, hypromellose 0.3% w/v, NDC 0536-1282-94), distributed by Rugby Laboratories;
• Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 mL (polyvinyl alcohol eye drops 1.4% w/v, NDC 0536-1325-94), distributed by Rugby Laboratories; • Multi-Action Relief Drops 15 mL (polyvinyl alcohol 0.5% w/v, povidone 0.6% w/v, tetrahydrozoline 0.05% eye drops, NDC 11822-2254-3), distributed by Rite Aid;
• Lubricating Gel Drops 10 mL (polyethylene glycol 400 0.4%, propylene glycol 0.3% eye drops, NDC 11822-4540-3), distributed by Rite Aid;
• Lubricant Eye Drops 10 mL, twin pack (propylene glycol eye drops 0.6% w/v, NDC 11822-4811-3), distributed by Rite Aid;
• Lubricant Gel Drops 15 mL (carboxymethylcellulose sodium eye drops 1.0% w/v, NDC 11822-4540-5), distributed by Rite Aid;
• Lubricant Eye Drops 15 mL, twin pack (carboxymethylcellulose sodium eye drops 0.5% w/v, NDC 11822-4811-5), distributed by Rite Aid;
• • Leader brand Eye Irritation Relief 15 mL (polyvinyl alcohol 0.5% w/v, povidone 0.6%w/v, tetrahydrozoline 0.05% eye drops, NDC 70000-0087-1), distributed by Cardinal Health; 
• Leader brand Dry Eye Relief 10 mL (polyethylene glycol 400 0.4%, propylene glycol 0.3% eye drops, NDC 70000-0088-1), distributed by Cardinal Health;
• Leader brand Dry Eye Relief 15 mL (carboxymethylcellulose sodium eye drops 1.0% w/v, NDC 70000-0089-1), distributed by Cardinal Health;
• Leader brand Lubricant Eye Drops 15 mL, single pack (carboxymethylcellulose sodium eye drops 0.5% w/v, NDC 70000-0090-1), distributed by Cardinal Health;
• Leader brand Lubricant Eye Drops 15 mL, twin pack (carboxymethylcellulose sodium eye drops 0.5% w/v, NDC 70000-0090-2), distributed by Cardinal Health;
• Leader brand Lubricant Eye Drops 10 mL (propylene glycol eye drops 0.6% w/v, NDC 70000-0587-1), distributed by Cardinal Health;
• Velocity Pharma brand Lubricant Eye Drops 10 mL, triple pack (propylene glycol eye drops 0.6% w/v, NDC 76168-502-30), distributed by Velocity Pharma;
• CVS Health brand Lubricant Eye Drops 15 mL, single pack (carboxymethylcellulose sodium eye drops 0.5% w/v, NDC 76168-702-15), distributed by CVS Pharmacy Inc.;
• CVS Health brand Lubricant Eye Drops 15 mL, twin pack (carboxymethylcellulose sodium eye drops 0.5% w/v, NDC 76168-702-30), distributed by CVS Pharmacy Inc.;
• CVS Health brand Lubricant Gel Drops 15 mL, single pack (carboxymethylcellulose sodium eye drops 1.0% w/v, NDC 76168-704-15), distributed by CVS Pharmacy Inc.;
• CVS Health brand Gel Drops 15 mL, twin pack (carboxymethylcellulose sodium eye drops 1.0% w/v, NDC 76168-704-30), distributed by CVS Pharmacy Inc.;
• CVS Health brand Multi Action Relief Drops 15 mL (polyvinyl alcohol 0.5% w/v, povidone 0.6% w/v, tetrahydrozoline 0.05% eye drops, NDC 76168-706-15), distributed by CVS Pharmacy Inc.;
• CVS Health brand Mild Moderate Lubricating Eye Drops 15 mL (polyethylene glycol 400 0.4% w/v, NDC 76168-711-15), distributed by CVS Pharmacy Inc.;
• CVS Health brand Lubricant Gel Drops 10 mL (polyethylene glycol 400 0.4%, propylene glycol 0.3% eye drops, NDC 76168-712-10), distributed by CVS Pharmacy Inc.;
• CVS Health brand Lubricant Eye Drops 10 mL, single pack (propylene glycol eye drops 0.6% w/v, NDC 76168-714-10), distributed by CVS Pharmacy Inc.;
• CVS Health brand Lubricant Eye Drops 10 mL, twin pack (propylene glycol eye drops 0.6% w/v, NDC 76168-714-20), distributed by CVS Pharmacy Inc.;
• Up & Up brand Dry Eye Relief 15 mL, twin pack (carboxymethylcellulose sodium eye drops 0.5% w/v, NDC 76168-800-30), distributed by Target Corporation;
• Target brand High Performance Lubricant Eye Drops 15 mL, single pack (polyethylene glycol 400 0.4%, propylene glycol 0.3%, NDC 11673-522-15), distributed by Target Corporation;
• Target brand High Performance Lubricant Eye Drops 15 mL, twin pack (polyethylene glycol 400 0.4%, propylene glycol 0.3%, NDC 11673-522-30), distributed by Target Corporation; and
• Equate brand Hydration PF Lubricant Eye Drops 10 mL (polyethylene glycol 400 0.4%, propylene glycol 0.3% eye drops, NDC 79903-168-01), distributed by Walmart.

“[T]here is a potential risk of eye infections or related harm. These products are intended to be sterile,” recalling firm Kilitch Healthcare India Limited, Mumbai, India, stated in a November 15, 2023, announcement. “Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.”

Kilitch Healthcare India Limited voluntarily initiated the recalls November 13, 2023. The FDA designated them Class I on February 5, 2024.