RecallRadar
ModerateReported September 30, 2026 (6 days ago)

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%

Recalled by Sterling Pharmaceutical Services LLC

Product image for AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15
Product image via news and web sources. It may show general packaging and not the exact recalled lot — always confirm using the codes below.

Class II — moderate

Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Sterling Pharmaceutical Services LLC has recalled AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on September 30, 2026 and was initiated on August 20, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, with approximately 12,864 packs affected. The company behind the recall is Sterling Pharmaceutical Services LLC, based in Dupo, IL. The FDA describes the product as: “AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15”

Why was AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% recalled?

According to the FDA, the stated reason for the recall is: “Lack of Assurance of Sterility.” In plain terms, this recall relates to a sterility or contamination concern.

Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.

What should you do?

If you think you may have bought AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, compare it against the product description and identifying codes (Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 33…) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Sterling Pharmaceutical Services LLC or your local health authority.

About this recall

This recall was distributed in IL. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.

Who this recall affects

This recall matters to anyone who bought AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%. Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.

Distribution listed in the notice: USA Nationwide.

What sterility or contamination concern actually means

Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.

In this case, the concern applies specifically to AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% from Sterling Pharmaceutical Services LLC — not to the wider category of products. Similar items from other brands aren't part of this recall.

How to check whether you have it

On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.

Compare what you find against the identifying details in this recall: Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027

What to do if you already bought it

Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.

Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.

If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.

Full recall details

Status
Ongoing
Date reported
September 30, 2026
Recall started
August 20, 2026
Distributed in
IL
What was recalled
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15
Why it was recalled (as stated by the FDA)
Lack of Assurance of Sterility
How to identify the affected product
Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027
Amount recalled
12,864 packs

What you can do

Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.

Quick answers

Why was AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% recalled?+

According to the FDA: Lack of Assurance of Sterility

How serious is this recall?+

Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

What should I do if I have AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%?+

Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.

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View the official FDA record →

Opens the U.S. Food and Drug Administration (FDA) data for this recall.

Recall number: D-0855-2026. Information last synced from the FDA on October 6, 2026.

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