The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0407-2025·Announced 2025-05-14

Lubricant Eye Drops Solution recalled due to sterility assurance concerns

BRS Analytical Services is recalling Lubricant Eye Drops Solution (Polyethylene Glycol 400 and Propylene Glycol) due to manufacturing deviations and lack of assurance of sterility. The product was distributed nationwide.

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: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are scored at 4 (Severe) when they involve risk of harm to health (in this case, loss of sterility assurance in an ophthalmic product), even without reported hospitalizations or confirmed adverse events.

Plain-English summary

BRS Analytical Services, LLC is recalling Lubricant Eye Drops Solution containing Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3%. The product is a sterile, moisturizing eye lubricant supplied in 0.5 FL OZ (15 mL) dropper bottles. This recall affects 13,104 cases (24 cartons per case) distributed nationwide in the USA under the brand name "Lubricant Eye Drops Solution."

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations and lack of assurance of sterility. Affected lots include: 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 (exp 11/05/26), Lot 201 (exp 11/10/26), Lot 202 (exp 11/13/26), Lot 203 (exp 11/18/26), Lot 204 (exp 11/21/26), Lot 205 (exp 11/25/26), Lot 206 (exp 12/02/26), Lot 219 (exp 2/24/27), Lot 221 (exp 3/02/27), and Lot 222 (exp 3/05/27). The product is identified by NDC 50268-126-15 and was distributed by AvKARE, Pulaski, TN 38478.

Consumers with affected product should stop use and contact their healthcare provider if they have any concerns. Healthcare providers and consumers may report adverse events to the FDA at www.fda.gov/medwatch or by phone at 1-888-SAFEFDA.

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 — Ophthalmic / Over-the-Counter
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 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.

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 manufacturer · BRS Analytical Services, LLC

See all →

Same hazard · sterility failure

See all →

Similar recalls