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

Carboxymethylcellulose Sodium Ophthalmic Gel recalled

BRS Analytical Services is recalling Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye, 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 114, exp 9/04/25; Lot 115, exp 9/06/25; Lot 116, exp 9/10/25; Lot 207, exp 12/05/26

Quantity recalled1,610 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-0405-2025
FDA event ID: 96741
Recalling firm: BRS Analytical Services, Saint Louis, MO
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 Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

cGMP deviations and lack of assurance of sterility.

Which lots are affected?

Lot, expiry: Lot 114, exp 9/04/25; Lot 115, exp 9/06/25; Lot 116, exp 9/10/25; Lot 207, exp 12/05/26

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

Other products in this recall event

4 other products · FDA event 96741

This product is part of a recall event; the main page for the event is Artificial Tears Ophthalmic Solution recalled by BRS Analytical Services.

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

More recalls from BRS Analytical Services

All 5

Reported	Class	Recall	Company	Reason	Where
14 May 2025Drug	CLASS II	Carboxymethylcellulose Sodium Ophthalmic Solution recalledCarboxymethylcellulose Sodium	BRS Analytical Services	Sterility	Nationwide
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	Artificial Tears Ophthalmic Solution recalled by BRS Analytical ServicesArtificial Tears	BRS Analytical Services	Sterility	Nationwide

Other Carboxymethylcellulose recalls

All 17

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Drug	CLASS II	Reliable-1 Laboratories Lubricating Tears, Sterile recalledLubricating Tears	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Walgreens Lubricant Eye Drops recalled by Sterling PharmaceuticalWalgreens Lubricant Eye Drops	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	Walgreens Lubricant Eye Drops Total Twin Pack recalledWalgreens Lubricant Eye Drops	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	AvKare Carboxymethylcellulose Sodium Ophthalmic Solution recalledCarboxymethylcellulose Sodium	Sterling Pharmaceutical Services	Sterility	Nationwide
30 Sep 2026Drug	CLASS II	AvKare Carboxymethylcellulose Sodium Ophthalmic Solution recalledCarboxymethylcellulose Sodium	Sterling Pharmaceutical Services	Sterility	Nationwide