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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 33,984
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
Same manufacturer · Kilitch Healthcare India Limited
See all →- CriticalFDA Recalls CVS Health Lubricating Eye Drops Due to Non-Sterility
FDA (Drugs) · 2024-02-14
- SevereDrug: Lubricant Eye Drops Recalled Nationwide Due to Non-Sterility
FDA (Drugs) · 2024-02-14
- SevereFDA recalls Leader brand Lubricant Eye Drops nationwide for non-sterility
FDA (Drugs) · 2024-02-14
- SevereFDA Recalls Non-Sterile Lubricant Eye Drops Due to Contamination Risk
FDA (Drugs) · 2024-02-14
- SevereDrug recall: Velocity Pharma Lubricating Eye Drops non-sterility risk
FDA (Drugs) · 2024-02-14
Same hazard · non sterility
See all →- SevereChloraPrep One-Step Antiseptic Solution Recall Due to Sterility Concerns
FDA (Drugs) · 2026-07-01
- SevereChloraPrep One-Step Topical Antiseptic Recalled for Non-Sterility
FDA (Drugs) · 2026-07-01
- SevereLSL Healthcare Infant Central Line Dressing Change Kit Recalled
FDA (Devices) · 2026-04-29
- HighLSL Healthcare Central Line Dressing Change Kit Recalled for Non-Sterility
FDA (Devices) · 2026-04-29
- HighLSL Healthcare Wound Closure Tray Model 7554 Recalled for Non-Sterility
FDA (Devices) · 2026-04-29
Similar recalls
- SevereEquate Restore Tears Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2019-11-27
- SevereAltaire Recalls Equate Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2019-11-27
- HighEquate Lubricant Eye Ointment Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2024-03-06
- SevereEquate Support Harmony Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2019-11-27
- HighEquate Stye Lubricant Eye Ointment recalled due to sterility assurance failure
FDA (Drugs) · 2024-03-06
- SevereSystane Lubricant Eye Drops Recalled for Non-Sterility Risk
FDA (Drugs) · 2025-01-22