Polyvinyl Alcohol 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
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.
Brand
BRS Analytical Services, LLC
Lot Codes / Batch Numbers
Lot, expiry: Lot 120, exp 10/02/25, Lot 122, exp 10/09/25, Lot 123, exp 10/12/25, Lot 124, exp 10/16/25, Lot 138, exp 1/08/26, Lot 142, exp 1/29/26, Lot 143, exp 2/01/26, Lot 144, exp 2/07/26, Lot 145, exp 2/12/26, Lot 146, exp 2/15/26, Lot 147, exp 2/21/26, Lot 148, exp 2/27/26, Lot 149, exp 3/04/26, Lot 150, exp 3/11/26, Lot 158, exp 4/15/26, Lot 159, exp 4/22/26, Lot 176, exp 7/24/26, Lot 177, exp 7/28/26, Lot 178, exp 7/31/26, Lot 179, exp 8/05/26.
Products Sold
Lot, expiry: Lot 120, exp 10/02/25; Lot 122, exp 10/09/25; Lot 123, exp 10/12/25; Lot 124, exp 10/16/25; Lot 138, exp 1/08/26; Lot 142, exp 1/29/26; Lot 143, exp 2/01/26; Lot 144, exp 2/07/26; Lot 145, exp 2/12/26; Lot 146, exp 2/15/26; Lot 147, exp 2/21/26; Lot 148, exp 2/27/26; Lot 149, exp 3/04/26; Lot 150, exp 3/11/26; Lot 158, exp 4/15/26; Lot 159, exp 4/22/26; Lot 176, exp 7/24/26; Lot 177, exp 7/28/26; Lot 178, exp 7/31/26; Lot 179, exp 8/05/26.
BRS Analytical Services, LLC is recalling Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (1 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.