Recall archive / FDA drug enforcement

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating... — FDA record D-0406-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 23, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15.
Reason: cGMP deviations and lack of assurance of sterility.
Classification: Class II
Recalling firm: BRS Analytical Services, LLC
Quantity: 32,876 cases (24 cartons per case)
Agency-reported status: Ongoing
Source record identifier: D-0406-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, exp 11/09/25; Lot 131, exp 11/14/25; Lot 132, exp 11/27/25; Lot 133, exp 11/30/25; Lot 134, exp 12/05/25; Lot 135, exp 12/11/25; Lot 136, exp 12/14/25; Lot 137, exp 1/02/26; Lot 139, exp 1/15/26; Lot 140, exp 1/19/26; Lot 141, exp 1/25/26; Lot 151, exp 3/18/26; Lot 152, exp 3/21/26; Lot 153, exp 3/25/26; Lot 154, exp 3/28/26; Lot 155, exp 4/01/26; Lot 156, exp 4/08/26; Lot 157, exp 4/11/26; Lot 160, exp 4/26/26; Lot 180, exp 8/08/26; Lot 181, exp 8/12/26; Lot 182, exp 8/18/26; Lot 183, exp 8/21/26; Lot 184, exp 8/26/26; Lot 185, exp 9/04/26; Lot 186, exp 9/09/26; Lot 187, exp 9/16/26; Lot 188, exp 9/18/26; Lot 189, exp 9/21/26; Lot 190, exp 9/25/26; Lot 191, exp 9/28/26; Lot 192, exp 10/02/26; Lot 208, exp 12/11/26; Lot 209, exp 12/16/26; Lot 212, exp 1/15/27; Lot 213, exp 1/21/27; Lot 214, exp 1/24/27; Lot 215, exp 2/02/27; Lot 216, exp 2/04/27; Lot 224, exp 3/27/27.

Label field

Details supplied by the agency

Lot, code or applicability

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, exp 11/09/25; Lot 131, exp 11/14/25; Lot 132, exp 11/27/25; Lot 133, exp 11/30/25; Lot 134, exp 12/05/25; Lot 135, exp 12/11/25; Lot 136, exp 12/14/25; Lot 137, exp 1/02/26; Lot 139, exp 1/15/26; Lot 140, exp 1/19/26; Lot 141, exp 1/25/26; Lot 151, exp 3/18/26; Lot 152, exp 3/21/26; Lot 153, exp 3/25/26; Lot 154, exp 3/28/26; Lot 155, exp 4/01/26; Lot 156, exp 4/08/26; Lot 157, exp 4/11/26; Lot 160, exp 4/26/26; Lot 180, exp 8/08/26; Lot 181, exp 8/12/26; Lot 182, exp 8/18/26; Lot 183, exp 8/21/26; Lot 184, exp 8/26/26; Lot 185, exp 9/04/26; Lot 186, exp 9/09/26; Lot 187, exp 9/16/26; Lot 188, exp 9/18/26; Lot 189, exp 9/21/26; Lot 190, exp 9/25/26; Lot 191, exp 9/28/26; Lot 192, exp 10/02/26; Lot 208, exp 12/11/26; Lot 209, exp 12/16/26; Lot 212, exp 1/15/27; Lot 213, exp 1/21/27; Lot 214, exp 1/24/27; Lot 215, exp 2/02/27; Lot 216, exp 2/04/27; Lot 224, exp 3/27/27.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the USA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: May 14, 2025
Recall initiation date: Apr 23, 2025
Center classification date: May 6, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.