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

Lubricant Eye Drops Solution recalled by BRS Analytical Services

BRS Analytical Services is recalling Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene, 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 117, exp 9/20/25; Lot 118, exp 9/25/25; Lot 119, exp 9/27/25; Lot 121, exp 10/05/25; Lot 161, exp 5/01/26; Lot 171, exp 6/18/26; Lot 172, exp 6/24/26; Lot 174, exp 7/01/26; Lot 175, exp 7/08/26; Lot 200, exp 11/05/26; Lot 201, exp 11/10/26; Lot 202, exp 11/13/26; Lot 203, exp 11/18/26; Lot 204, exp 11/21/26; Lot 205, exp 11/25/26; Lot 206, exp 12/02/26; Lot 219, exp 2/24/27; Lot 221, exp 3/02/27; Lot 222, exp 3/05/27.

NDC50268-126

Quantity recalled13,104 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-0407-2025
FDA event ID: 96741
Recalling firm: BRS Analytical Services, Saint Louis, MO
Brand: Lubricant Eye Drops Solution
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: Stomach & Acid Reflux Medication

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

Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.

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 117, exp 9/20/25; Lot 118, exp 9/25/25; Lot 119, exp 9/27/25; Lot 121, exp 10/05/25; Lot 161, exp 5/01/26; Lot 171, exp 6/18/26; Lot 172, exp 6/24/26; Lot 174, exp 7/01/26; Lot 175, exp 7/08/26; Lot 200, exp 11/05/26; Lot 201, exp 11/10/26; Lot 202, exp 11/13/26; Lot 203, exp 11/18/26; Lot 204, exp 11/21/26; Lot 205, exp 11/25/26; Lot 206, exp 12/02/26; Lot 219, exp 2/24/27; Lot 221, exp 3/02/27; Lot 222, exp 3/05/27.

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 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	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	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	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 Polyethylene Glycol 400 recalls

All 3

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Drug	CLASS II	Ultra Lubricating Eye Drops (polyethylene recalledLeader Ultra Lubricating Eye Drops	K.C. Pharmaceuticals	Sterility	Nationwide
17 Aug 2022Drug	CLASS II	Systane, Lubricant Eye Drops recalled by Mckesson Medical-SurgicalSystane Lubricant	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide