The Recall Desk
Agency classClass IIOur severity:SevereFDA (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 (0.5 FL OZ dropper bottles) nationwide due to manufacturing deviations and lack of assured sterility. Affected lots are Lot 126–129, 162–170, and 193–199.

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 sterile drug manufacturing deviations and loss of sterility assurance in an ophthalmic solution. Class II recalls by definition carry serious potential for adverse health consequences, meeting the "Severe" threshold even absent reported illnesses.

Plain-English summary

BRS Analytical Services, LLC is recalling Artificial Tears Ophthalmic Solution (Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3%), distributed by AvKARE (Pulaski, TN), NDC 50268-043-15, due to current good manufacturing practice (cGMP) deviations and lack of assurance of sterility. The product is a sterile lubricant eye drop supplied in 0.5 FL OZ (15 mL) dropper bottles.

The recall affects 13,872 cases (24 cartons per case) distributed nationwide in the USA. The affected lots and expiration dates are: 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 (exp 6/03/26), Lot 168 (exp 6/06/26), Lot 169 (exp 6/10/26), Lot 170 (exp 6/13/26), Lot 193 (exp 10/07/26), Lot 194 (exp 10/10/26), Lot 195 (exp 10/14/26), Lot 196 (exp 10/17/26), Lot 197 (exp 10/21/26), Lot 198 (exp 10/24/26), and Lot 199 (exp 10/30/26).

Consumers should stop using the recalled product and contact their healthcare provider if they have questions or have experienced any problems. Healthcare providers and distributors should quarantine affected lots and return them according to FDA guidance.

The recalled product

Product
ARTIFICIAL TEARS (ARTIFICIAL TEARS)
Brand
ARTIFICIAL TEARS
Manufacturer
BRS Analytical Services, LLC
Category
Drug — Ophthalmic / Eye Lubricant
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 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.

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 →

Related recalls

Same brand · ARTIFICIAL TEARS

Same manufacturer · BRS Analytical Services, LLC

See all →

Same hazard · sterility assurance

See all →

Similar recalls