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

Artificial Tears Ophthalmic Solution recalled by BRS Analytical Services

BRS Analytical Services is recalling Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (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 126, exp 10/26/25; Lot 127, exp 10/30/25; Lot 128, exp 11/02/25; Lot 129, exp 11/06/25; Lot 162, exp 5/09/26; Lot 163, exp 5/14/26; Lot 164, exp 5/20/26; Lot 165, exp 5/23/26; Lot 166, exp 5/29/26; Lot 167, exp 6/03/26; Lot 168, exp 6/06/26; Lot 169, exp 6/10/26; Lot 170, exp 6/13/26; Lot 193, exp 10/07/26; Lot 194, exp 10/10/26; Lot 195, exp 10/14/26; Lot 196, exp 10/17/26; Lot 197, exp 10/21/26; Lot 198, exp 10/24/26; Lot 199, exp 10/30/26.

NDC50268-043

Quantity recalled13,872 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-0404-2025
FDA event ID: 96741
Recalling firm: BRS Analytical Services, Saint Louis, MO
Brand: Artificial Tears
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

Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.

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 126, exp 10/26/25; Lot 127, exp 10/30/25; Lot 128, exp 11/02/25; Lot 129, exp 11/06/25; Lot 162, exp 5/09/26; Lot 163, exp 5/14/26; Lot 164, exp 5/20/26; Lot 165, exp 5/23/26; Lot 166, exp 5/29/26; Lot 167, exp 6/03/26; Lot 168, exp 6/06/26; Lot 169, exp 6/10/26; Lot 170, exp 6/13/26; Lot 193, exp 10/07/26; Lot 194, exp 10/10/26; Lot 195, exp 10/14/26; Lot 196, exp 10/17/26; Lot 197, exp 10/21/26; Lot 198, exp 10/24/26; Lot 199, exp 10/30/26.

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

Reported	Class	Recall	Company	Reason	Where
14 May 2025	CLASS II	Carboxymethylcellulose Sodium Ophthalmic Gel recalled	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	Carboxymethylcellulose Sodium Ophthalmic Gel recalled	BRS Analytical Services	Sterility	Nationwide

Other Artificial Tears recalls

All 6

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Artificial Tears Solution, Polyvinyl Alcohol recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Artificial Tears Ointment, Sterile, For Ophthalmic Use Only tubes recalled	Akorn	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Artificial Tears Solution, Lubricant Eye Drops recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide
25 Jan 2023Drug	CLASS II	Artificial Tears Ointment, Lubricant Eye Ointment recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide
8 Sep 2021Drug	CLASS II	Artificial Tears Ointment, Lubricant Eye Ointment recalled by Akorn	Akorn	Other Bacterial Contamination	Nationwide