CVS Health Lubricant Eye Drops Recalled for Non-Sterility
CVS Health brand Lubricant Eye Drops are recalled due to non-sterility. All lots distributed nationwide are affected; consumers should discontinue use.
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 requires a minimum severity score of 4. While no illnesses or injuries have been reported, the non-sterility of eye drops—a product applied directly to sensitive ocular tissue—represents a significant contamination risk that justifies the Class I regulatory classification.
Plain-English summary
CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%) are subject to an FDA Class I recall. The affected product is packaged in 0.33 FL OZ bottles in two configurations: single pack (NDC 76168-714-10) and twin pack (NDC 76168-714-20). Approximately 137,784 bottles were distributed nationwide within the United States. The product is manufactured by Kilitch Healthcare India Limited and distributed by CVS Pharmacy Inc.
The recall was initiated due to non-sterility of the product. The manufacturer voluntarily initiated the recall on November 13, 2023, and the FDA confirmed the Class I classification on February 5, 2024. All lots of the product are affected.
Consumers who have purchased CVS Health Lubricant Eye Drops should discontinue use immediately. Retailers should remove the affected product from shelves. For information on how to handle already-purchased bottles or obtain refunds, consumers should contact CVS Pharmacy or visit the FDA's Drug Recalls website.
The recalled product
- Product
- CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Eye Drops
- Affected units
- 137,784
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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