FDA Recalls Rugby Lubricating Tears Eye Drops for Non-Sterility
Rugby brand Lubricating Tears Eye Drops have been recalled nationwide for non-sterility. Kilitch Healthcare India Limited initiated the voluntary recall of 56,520 bottles due to potential contamination concerns.
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: This is an FDA Class I recall, which indicates a serious health risk and per FDA guidance never scores below 4. The source does not report any illnesses, injuries, or deaths, so this is classified as Severe (4) rather than Critical (5).
Plain-English summary
Rugby brand Lubricating Tears Eye Drops, containing Dextran 70 0.1% and Hypromellose 2910 0.3%, are being recalled. The product is packaged in 0.5 FL OZ (15 mL) bottles and distributed by Rugby Laboratories in Livonia, Michigan, nationwide within the United States.
Kilitch Healthcare India Limited initiated a voluntary recall of 56,520 bottles on November 13, 2023, due to non-sterility concerns affecting all lots of the product. The FDA classified this as a Class I recall on February 5, 2024.
Non-sterile eye drops pose a risk of contamination. Consumers should discontinue use of this product and consult a healthcare provider if they have experienced any eye-related symptoms after using the product.
The recalled product
- Product
- Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Eye Drops
- Hazard
- Affected units
- 56,520
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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