Artificial Tears Solution (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
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.
Brand
BRS Analytical Services, LLC
Lot Codes / Batch Numbers
Lot, expiry: Lot 126, exp 10/26/25, Lot 127, exp 10/30/25, Lot 128, exp 11/02/25, Lot 129, exp 11/06/25, Lot 162, exp 5/09/26, Lot 163, exp 5/14/26, Lot 164, exp 5/20/26, Lot 165, exp 5/23/26, Lot 166, exp 5/29/26, Lot 167, exp 6/03/26, Lot 168, exp 6/06/26, Lot 169, exp 6/10/26, Lot 170, exp 6/13/26, Lot 193, exp 10/07/26, Lot 194, exp 10/10/26, Lot 195, exp 10/14/26, Lot 196, exp 10/17/26, Lot 197, exp 10/21/26, Lot 198, exp 10/24/26, Lot 199, exp 10/30/26.
Products Sold
Lot, expiry: Lot 126, exp 10/26/25; Lot 127, exp 10/30/25; Lot 128, exp 11/02/25; Lot 129, exp 11/06/25; Lot 162, exp 5/09/26; Lot 163, exp 5/14/26; Lot 164, exp 5/20/26; Lot 165, exp 5/23/26; Lot 166, exp 5/29/26; Lot 167, exp 6/03/26; Lot 168, exp 6/06/26; Lot 169, exp 6/10/26; Lot 170, exp 6/13/26; Lot 193, exp 10/07/26; Lot 194, exp 10/10/26; Lot 195, exp 10/14/26; Lot 196, exp 10/17/26; Lot 197, exp 10/21/26; Lot 198, exp 10/24/26; Lot 199, exp 10/30/26.
BRS Analytical Services, LLC is recalling Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants 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.