FDA Recalls Dry Eye Relief Drops Nationwide Due to Non-Sterility
The FDA has issued a Class I recall of Dry Eye Relief eye drops sold nationwide due to non-sterility concerns. The manufacturer, Kilitch Healthcare India Limited, initiated the voluntary recall affecting 12,960 bottles.
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 recalls carry a minimum severity score of 4 per the rubric. Non-sterility in an ophthalmic product poses significant risk of contamination and serious eye infection.
Plain-English summary
Dry Eye Relief eye drops containing Polyethylene glycol 400 0.4% and Propylene glycol 0.3% are being recalled. The product is sold in 0.33 FL OZ (10 mL) bottles under the Leader brand and distributed by Cardinal Health (NDC 70000-0088-1) nationwide within the United States. The recall involves 12,960 bottles and affects all lots of the product.
The manufacturer, Kilitch Healthcare India Limited, initiated this voluntary recall beginning November 13, 2023, due to non-sterility. The FDA classified this as a Class I recall on February 5, 2024.
This recall affects all consumers who obtained the product nationwide within the United States.
The recalled product
- Product
- DRY EYE RELIEF (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL)
- Brand
- DRY EYE RELIEF
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Ophthalmic / Eye Drops
- Affected units
- 12,960
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.
Part of a larger recall action
This product is one of 22 recalled by Kilitch Healthcare India Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
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