FDA recalls non-sterile EQUATE lubricant eye drops nationwide
Walmart's EQUATE brand Hydration PF Lubricant Eye Drops are being recalled due to non-sterility. This FDA Class I recall affects 33,984 bottles distributed nationwide.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall for non-sterile ophthalmic drops. The FDA's Class I classification identifies products with serious hazards requiring immediate action, qualifying this as Critical severity.
Plain-English summary
Walmart Inc. is recalling EQUATE brand Hydration PF Lubricant Eye Drops in 0.34 FL OZ (10 mL) bottles due to non-sterility. The manufacturer, Kilitch Healthcare India Limited, initiated this voluntary Class I recall on November 13, 2023. The product contains Polyethylene glycol 400 0.4% and Propylene glycol 0.3% and carries NDC 79903-168-01.
A total of 33,984 bottles were distributed nationwide within the United States. All lots of the affected product are included in this recall.
Consumers who have purchased this product should stop using it and dispose of it safely. Non-sterile eye drops can introduce bacteria or other microorganisms to the eyes, potentially causing infections or other complications. Anyone with questions or concerns should contact Walmart or speak with their healthcare provider.
The recalled product
- Product
- EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Ophthalmic Eye Drops
- Hazard
- non-sterility
- infection-risk
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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