CLASS II ONGOING Drug recall · Reported 14 May 2025 · FDA Enforcement Report

Carboxymethylcellulose Sodium Ophthalmic Solution recalled

BRS Analytical Services is recalling Carboxymethylcellulose Sodium Ophthalmic Solution 5%, Carboxymethlycellulose Sodium 5%, distributed nationwide in the US. The recall was initiated on 23 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot, 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.

NDC50268-068

Quantity recalled32,876 cases (24 cartons per case)

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0406-2025
FDA event ID: 96741
Recalling firm: BRS Analytical Services, Saint Louis, MO
Brand: Carboxymethylcellulose Sodium
Manufacturer: AvPAK
Classification: Class II
Status: Ongoing
Recall initiated: 23 Apr 2025
FDA classified: 6 May 2025
Reported: 14 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Eye Drops

Timeline

23 Apr 2025	Recall initiated by company
6 May 2025	Classified by FDA	+13 days
14 May 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

cGMP deviations and lack of assurance of sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Is Carboxymethylcellulose Sodium Ophthalmic Solution 5%, Carboxymethlycellulose Sodium 5% recalled?

Yes. BRS Analytical Services recalled Carboxymethylcellulose Sodium Ophthalmic Solution 5%, Carboxymethlycellulose Sodium 5% on 23 Apr 2025. The recall is Class II and its status is Ongoing. Recall number D-0406-2025.

Why was it recalled?

cGMP deviations and lack of assurance of sterility.

Which lots are affected?

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.

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from BRS Analytical Services

All 5

Reported	Class	Recall	Company	Reason	Where
14 May 2025Drug	CLASS II	Lubricant Eye Drops Solution recalled by BRS Analytical ServicesLubricant Eye Drops Solution	BRS Analytical Services	Sterility	Nationwide
14 May 2025Drug	CLASS II	Polyvinyl Alcohol Ophthalmic Solution recalledPolyvinyl Alcohol	BRS Analytical Services	Sterility	Nationwide
14 May 2025Drug	CLASS II	Carboxymethylcellulose Sodium Ophthalmic Gel recalled	BRS Analytical Services	Sterility	Nationwide
14 May 2025Drug	CLASS II	Artificial Tears Ophthalmic Solution recalled by BRS Analytical ServicesArtificial Tears	BRS Analytical Services	Sterility	Nationwide

Other Carboxymethylcellulose recalls

All 7

Reported	Class	Recall	Company	Reason	Where
8 Jan 2025Drug	CLASS III	Carboxymethylcellulose Sodium Ophthalmic Solution recalled by AvKARECarboxymethylcellulose Sodium	AvKARE	Packaging Defects	Nationwide
14 Feb 2024Drug	CLASS I	Leader Dry Eye Relief (Carboxymethylcellulose Sodium 1%) recalledDry Eye Relief	Kilitch Healthcare India	Sterility	Nationwide
14 Feb 2024Drug	CLASS I	Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium 5%) recalledLubricant Drops	Kilitch Healthcare India	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium, 5%) recalledLubricant Drops	Cardinal Health	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Leader Dry Eye Relief (Carboxymethylcellulose Sodium, 1%) recalledDry Eye Relief	Cardinal Health	Sterility	Nationwide