The Recall Desk
HighFDA (Drugs)·D-0404-2025·Announced 2025-05-14

Artificial Tears Eye Drops Recalled for Manufacturing and Sterility Issues

BRS Analytical Services is recalling Artificial Tears Ophthalmic Solution due to current Good Manufacturing Practice deviations and lack of sterility assurance. The nationwide recall affects 13,872 cases.

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: FDA Class II recall affecting a sterile ophthalmic product due to manufacturing deviations and lack of sterility assurance. No illnesses or injuries reported. Per the rubric, risk-of-harm products without reported injury score as High.

Plain-English summary

BRS Analytical Services, LLC, in cooperation with the FDA, is recalling Artificial Tears Ophthalmic Solution (Dextran 70 0.01%, Glycerin 0.2%, Hypromellose 0.3%) distributed by AvKARE in Pulaski, Tennessee. The affected product is a sterile eye lubricant provided in 0.5 fl oz (15 mL) dropper bottles.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations and lack of assurance of sterility in the affected batches. These manufacturing issues raise concerns about product safety and integrity.

The recall affects 13,872 cases distributed nationwide. Affected lots include Lot numbers 126 through 170 with expiration dates ranging from October 26, 2025, to October 30, 2026. Customers should check the lot and expiration date on their bottles.

Consumers should stop using the affected product and consult their healthcare provider or pharmacist with questions. The product should be disposed of according to local pharmaceutical waste guidelines or returned to the point of purchase.

The recalled product

Product
ARTIFICIAL TEARS (ARTIFICIAL TEARS)
Brand
ARTIFICIAL TEARS
Manufacturer
BRS Analytical Services, LLC
Category
Drug — Ophthalmic Eye Drops
Hazard
  • contamination-risk
  • manufacturing-defect

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 126
  • exp 10/26/25
  • Lot 127
  • exp 10/30/25
  • Lot 128
  • exp 11/02/25
  • Lot 129
  • exp 11/06/25
  • Lot 162
  • exp 5/09/26
  • Lot 163
  • exp 5/14/26
  • Lot 164
  • exp 5/20/26
  • Lot 165
  • exp 5/23/26
  • Lot 166
  • exp 5/29/26
  • Lot 167

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · ARTIFICIAL TEARS

Same category