The Recall Desk
SevereFDA (Drugs)·D-0406-2025·Announced 2025-05-14

Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns

BRS Analytical Services is recalling Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% eye lubricant nationwide due to cGMP deviations and lack of assurance of sterility. The recalled product was distributed in 0.5 FL OZ dropper bottles across multiple lots with various expiration dates in 2025 and 2026.

What this means for you

Illness, injury, or structural failure has been reported. 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 a sterile ophthalmic drug product with cGMP deviations and lack of assurance of sterility. Per the rubric, FDA Class II recalls with documented manufacturing or safety defects that affect sterile products warrant a Severe classification, even absent reported illnesses.

Plain-English summary

BRS Analytical Services, LLC is recalling Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, a sterile lubricating eye drop product sold in 0.5 FL OZ (15mL) dropper bottles under the brand name Carboxymethylcellulose Sodium. The product is distributed by AvKARE in Pulaski, Tennessee and has NDC 50268-068-15. A total of 32,876 cases (24 cartons per case) were distributed nationwide in the USA.

The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations and lack of assurance of sterility. Multiple lots are affected, with expiration dates ranging from April 2025 through March 2027. Affected lot numbers include Lots 103, 104, 108, 109, 110, 111, 112, 113, 125, 130, 131, 132, 133, 134, 135, 136, 137, 139, 140, 141, 151, 152, 153, 154, 155, 156, 157, 160, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 208, 209, 212, 213, 214, 215, 216, and 224.

Consumers who have purchased this product should stop using it. Patients should consult their healthcare provider about alternative eye lubricant products.

The recalled product

Product
CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE SODIUM)
Brand
CARBOXYMETHYLCELLULOSE SODIUM
Manufacturer
BRS Analytical Services, LLC
Category
Drug — Ophthalmic / Eye Care
Hazard
  • sterility-defect
  • 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 103
  • exp 4/26/25
  • Lot 104
  • exp 5/03/25
  • Lot 108
  • exp 6/29/25
  • Lot 109
  • exp 7/18/25
  • Lot 110
  • exp 8/17/25
  • Lot 111
  • exp 8/22/25
  • Lot 112
  • exp 8/27/25
  • Lot 113
  • exp 9/18/25
  • Lot 125
  • exp 10/23/25
  • Lot 130

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · CARBOXYMETHYLCELLULOSE SODIUM

Same category