The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0408-2025·Announced 2025-05-14

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.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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

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.

Part of a larger recall action

This product is one of 5 recalled by BRS Analytical Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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