Polyvinyl Alcohol Eye Drops Recalled for Manufacturing and Sterility Issues
BRS Analytical Services is recalling Polyvinyl Alcohol Ophthalmic Solution 1.4% eye drops nationwide due to cGMP deviations and lack of assurance of sterility.
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 II recall involving a sterile ophthalmic product with documented cGMP deviations and lack of assurance of sterility. Per the rubric, FDA Class II recalls with significant risk to health (sterile product integrity failure) meet the Severe threshold.
Plain-English summary
BRS Analytical Services, LLC is recalling Polyvinyl Alcohol Ophthalmic Solution 1.4% (lubricant eye drops) distributed by AvKARE in Pulaski, TN. The recall affects 14,333 cases nationwide across multiple lot numbers and expiration dates ranging from October 2025 through August 2026.
The product is being recalled due to current good manufacturing practice (cGMP) deviations and lack of assurance of sterility. The affected product is a sterile ophthalmic solution delivered in 0.5 FL OZ (15 mL) dropper bottles, NDC 50268-678-15.
Consumers who have purchased this product should stop using it immediately and contact their pharmacy or healthcare provider. The product should not be used in the eyes due to the sterility concerns.
The recalled product
- Product
- POLYVINYL ALCOHOL (POLYVINYL ALCOHOL)
- Brand
- POLYVINYL ALCOHOL
- Manufacturer
- BRS Analytical Services, LLC
- Category
- Drug — Ophthalmic / Eye Drops
- Hazard
- sterility-failure
- cGMP-deviation
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 (20)
- 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · POLYVINYL ALCOHOL
- ModerateEye drops recalled nationwide due to labeling mix-up
FDA (Drugs) · 2025-01-08
Same category
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateClinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide
FDA (Drugs) · 2026-07-22