FDA Recalls Lubricant Eye Drops Due to Non-Sterility
Rite Aid is recalling all lots of Lubricant Gel Drops due to non-sterility concerns. The product was distributed nationwide.
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 per the severity rubric requires a minimum score of 4 (Severe). Non-sterility in an ophthalmic product presents a direct health risk of infection.
Plain-English summary
Rite Aid is recalling all lots of Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 (NDC 11822-4540-3).
The recall was initiated due to non-sterility concerns. The product was classified as an FDA Class I recall, indicating a serious health hazard.
The recalled product was distributed nationwide throughout the United States. A total of 7,776 bottles across all lots were affected by this recall.
Consumers should discontinue use of this product. The manufacturer, Kilitch Healthcare India Limited, initiated this voluntary recall on November 13, 2023.
The recalled product
- Product
- Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Ophthalmic / Eye Care
- Hazard
- Affected units
- 7,776
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