FDA Recalls Non-Sterile Lubricant Eye Drops Due to Contamination Risk
The FDA recalled approximately 210,192 bottles of Leader brand Lubricant Eye Drops due to non-sterility that could allow contamination. All lots distributed nationwide are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification for drugs requires a minimum severity of Severe (4). No hospitalizations, serious injuries, or deaths have been reported. The hazard is potential contamination from non-sterility affecting an ophthalmic product.
Plain-English summary
The FDA has issued a Class I recall of Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), manufactured by Kilitch Healthcare India Limited. The affected product was distributed nationwide in approximately 210,192 bottles in two package formats: single packs and twin packs (NDC 70000-0090-1 and 70000-0090-2).
The recall was issued because the product failed to meet sterility requirements. Non-sterile eye drops can become contaminated with harmful microorganisms that may cause eye infections or other complications.
Cardinal Health (Dublin, Ohio) distributed the product under the Leader brand. This voluntary recall was initiated by the manufacturer starting November 13, 2023.
Consumers should stop using this product immediately. Anyone who has experienced eye symptoms such as redness, pain, irritation, or discharge after using the product should consult a healthcare provider.
The recalled product
- Product
- LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
- Brand
- LUBRICANT DROPS
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Eye Drops
- Hazard
- non-sterile
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
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