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

Polyvinyl Alcohol Ophthalmic Solution recalled

BRS Analytical Services is recalling Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 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 120, exp 10/02/25; Lot 122, exp 10/09/25; Lot 123, exp 10/12/25; Lot 124, exp 10/16/25; Lot 138, exp 1/08/26; Lot 142, exp 1/29/26; Lot 143, exp 2/01/26; Lot 144, exp 2/07/26; Lot 145, exp 2/12/26; Lot 146, exp 2/15/26; Lot 147, exp 2/21/26; Lot 148, exp 2/27/26; Lot 149, exp 3/04/26; Lot 150, exp 3/11/26; Lot 158, exp 4/15/26; Lot 159, exp 4/22/26; Lot 176, exp 7/24/26; Lot 177, exp 7/28/26; Lot 178, exp 7/31/26; Lot 179, exp 8/05/26.

NDC50268-678

Quantity recalled14,333 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-0408-2025
FDA event ID: 96741
Recalling firm: BRS Analytical Services, Saint Louis, MO
Brand: Polyvinyl Alcohol
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

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.

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 120, exp 10/02/25; Lot 122, exp 10/09/25; Lot 123, exp 10/12/25; Lot 124, exp 10/16/25; Lot 138, exp 1/08/26; Lot 142, exp 1/29/26; Lot 143, exp 2/01/26; Lot 144, exp 2/07/26; Lot 145, exp 2/12/26; Lot 146, exp 2/15/26; Lot 147, exp 2/21/26; Lot 148, exp 2/27/26; Lot 149, exp 3/04/26; Lot 150, exp 3/11/26; Lot 158, exp 4/15/26; Lot 159, exp 4/22/26; Lot 176, exp 7/24/26; Lot 177, exp 7/28/26; Lot 178, exp 7/31/26; Lot 179, exp 8/05/26.

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	Carboxymethylcellulose Sodium Ophthalmic Gel recalled	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	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 Polyvinyl Alcohol recalls

All 5

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Drug	CLASS II	Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml	K.C. Pharmaceuticals	Sterility	Nationwide
8 Jan 2025Drug	CLASS III	Polyvinyl Alcohol Ophthalmic Solution recalled by AvKAREPolyvinyl Alcohol	AvKARE	Packaging Defects	Nationwide
14 Feb 2024Drug	CLASS I	Leader Eye Irritation Relief (Polyvinyl alcohol recalledEyes Irritation Relief	Kilitch Healthcare India	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Leader Eye Irritation Relief (Polyvinyl alcohol recalledEyes Irritation Relief	Cardinal Health	Sterility	Nationwide