Kareway Recalls Gericare Eyewash Due to Confirmed Microbial Contamination
Kareway Products Inc. is recalling 60,000 bottles of Gericare Eyewash because testing confirmed the presence of Achromobacter xylosoxidans bacteria.
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: The agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 5.
Plain-English summary
Kareway Products Inc. is voluntarily recalling 60,000 bottles of Gericare Eyewash, a sterile eye irrigating solution. The product is packaged in 4 fl oz (118 mL) bottles and is available over the counter. The specific lot affected is 86041601, with an expiration date of 09/19.
The recall was initiated because testing confirmed that the product was non-sterile and contained Achromobacter xylosoxidans. This microbial contamination means the solution does not meet the required sterility standards for eye irrigation.
The product was shipped to Geri-Care Pharmaceuticals Corp., which distributed it nationwide in the United States. Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the bottles.
The recalled product
- Product
- GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04
- Manufacturer
- Kareway Products Inc
- Category
- Drug — Ophthalmic
- Affected units
- 60,000
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 (2)
- Lot #: 86041601
- Exp 09/19
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · microbial contamination
See all →- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- SevereAltaire Sterile Eye Wash Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2019-11-27
- SevereUnited Exchange Recalls Eye Irrigating Solution Due to Sterility Concerns
FDA (Drugs) · 2017-03-08
- SevereAltaire Sterile Eye Wash Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-11-27
- SevereEzriCare Artificial Tears Eye Drops Recalled for Bacterial Contamination
FDA (Drugs) · 2023-07-19
- SevereAltaire Sterile Eye Wash Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2019-11-27
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19