Lubricant Eye Drops (BRS Analytical) - Sterility Concern (2025)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.
Brand
BRS Analytical Services, LLC
Lot Codes / Batch Numbers
Lot, expiry: Lot 117, exp 9/20/25, Lot 118, exp 9/25/25, Lot 119, exp 9/27/25, Lot 121, exp 10/05/25, Lot 161, exp 5/01/26, Lot 171, exp 6/18/26, Lot 172, exp 6/24/26, Lot 174, exp 7/01/26, Lot 175, exp 7/08/26, Lot 200, exp 11/05/26, Lot 201, exp 11/10/26, Lot 202, exp 11/13/26, Lot 203, exp 11/18/26, Lot 204, exp 11/21/26, Lot 205, exp 11/25/26, Lot 206, exp 12/02/26, Lot 219, exp 2/24/27, Lot 221, exp 3/02/27, Lot 222, exp 3/05/27.
Products Sold
Lot, expiry: Lot 117, exp 9/20/25; Lot 118, exp 9/25/25; Lot 119, exp 9/27/25; Lot 121, exp 10/05/25; Lot 161, exp 5/01/26; Lot 171, exp 6/18/26; Lot 172, exp 6/24/26; Lot 174, exp 7/01/26; Lot 175, exp 7/08/26; Lot 200, exp 11/05/26; Lot 201, exp 11/10/26; Lot 202, exp 11/13/26; Lot 203, exp 11/18/26; Lot 204, exp 11/21/26; Lot 205, exp 11/25/26; Lot 206, exp 12/02/26; Lot 219, exp 2/24/27; Lot 221, exp 3/02/27; Lot 222, exp 3/05/27.
BRS Analytical Services, LLC is recalling Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye due to cGMP deviations and lack of assurance of sterility.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP deviations and lack of assurance of sterility.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 7, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.