The Recall Desk
HighFDA (Drugs)·D-0408-2025·Announced 2025-05-14

Polyvinyl Alcohol Eye Drops Recalled for Sterility and Manufacturing Issues

BRS Analytical Services is recalling Polyvinyl Alcohol ophthalmic solution due to cGMP deviations and lack of sterility assurance. Consumers should stop using affected lots immediately.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for manufacturing deviations affecting sterility assurance in an ophthalmic product. No illnesses or injuries have been reported, but the potential for serious eye infections exists if the product is non-sterile, warranting a High severity rating.

Plain-English summary

BRS Analytical Services, LLC is recalling Polyvinyl Alcohol Ophthalmic Solution 1.4%, a lubricating eye drop product distributed nationwide by AvKARE. The recalled product is supplied in 0.5 FL OZ (15mL) dropper bottles with NDC 50268-678-15. Approximately 14,333 cases are affected across 20 different lot numbers.

The recall was issued due to cGMP (current Good Manufacturing Practice) deviations and lack of assurance of sterility. These manufacturing deficiencies indicate the product may not be adequately sterile, creating a potential safety risk for ophthalmic use.

Affected lot numbers range from Lot 120 (expiring 10/02/25) through Lot 179 (expiring 8/05/26). Consumers in possession of this product should discontinue use immediately. Those who have used the recalled product and subsequently experience eye discomfort, irritation, or redness should contact a healthcare provider.

The recalled product

Product
POLYVINYL ALCOHOL (POLYVINYL ALCOHOL)
Brand
POLYVINYL ALCOHOL
Manufacturer
BRS Analytical Services, LLC
Category
Drug — Ophthalmic
Hazard
  • sterility-issue
  • 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

Same category