The Recall Desk
HighFDA (Drugs)·D-0407-2025·Announced 2025-05-14

Lubricant Eye Drops Solution Recalled for Sterility and Manufacturing Defects

BRS Analytical Services recalled Lubricant Eye Drops Solution nationwide due to cGMP deviations and lack of sterility assurance. The product may carry contamination risk and should not be used.

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 sterility and manufacturing defects in a product applied directly to the eye. No illnesses or injuries have been reported; the hazard is the potential for microbial contamination due to manufacturing control failures. According to the rubric, Class II recalls without reported harm and with theoretical hazards are scored as High (3).

Plain-English summary

BRS Analytical Services, LLC has recalled Lubricant Eye Drops Solution (containing Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3%), distributed by AvKARE of Pulaski, Tennessee. The recall affects approximately 13,104 cases distributed nationwide in the United States.

The recall was issued due to current Good Manufacturing Practice (cGMP) deviations and lack of assurance that the product maintains sterility. These manufacturing defects could potentially result in contamination of the eye drops.

The affected lot numbers are: 117 (exp. 9/20/25), 118 (exp. 9/25/25), 119 (exp. 9/27/25), 121 (exp. 10/05/25), 161 (exp. 5/01/26), 171 (exp. 6/18/26), 172 (exp. 6/24/26), 174 (exp. 7/01/26), 175 (exp. 7/08/26), 200 (exp. 11/05/26), 201 (exp. 11/10/26), 202 (exp. 11/13/26), 203 (exp. 11/18/26), 204 (exp. 11/21/26), 205 (exp. 11/25/26), 206 (exp. 12/02/26), 219 (exp. 2/24/27), 221 (exp. 3/02/27), and 222 (exp. 3/05/27).

Consumers who have purchased this product should stop using it immediately and consult their healthcare provider.

The recalled product

Product
LUBRICANT EYE DROPS SOLUTION (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL)
Brand
LUBRICANT EYE DROPS SOLUTION
Manufacturer
BRS Analytical Services, LLC
Category
Drug — Eye Drops
Hazard
  • manufacturing-defect
  • sterility-assurance

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 117
  • exp 9/20/25
  • Lot 118
  • exp 9/25/25
  • Lot 119
  • exp 9/27/25
  • Lot 121
  • exp 10/05/25
  • Lot 161
  • exp 5/01/26
  • Lot 171
  • exp 6/18/26
  • Lot 172
  • exp 6/24/26
  • Lot 174
  • exp 7/01/26
  • Lot 175
  • exp 7/08/26
  • Lot 200

Distribution

Distributed nationwide across the United States.

Related recalls

Same category