Lower risk Drug recall · FDA · Published December 18, 2024

AvKARE Eye Drops Label Mix-Up Recall: 0.5% Moisturizing Lubricant

AvKARE recalls 0.5% moisturizing lubricant eye drops due to labeling mix-up. No immediate danger but check if you have the specific lot number.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0175-2025Drug AvKARE ›

Lower-risk recall

LABELING: LABEL MIX-UP

Take action

Contact the company

Recalling firmAvKARE615 N 1st St · Pulaski, TN 38478-2403

✎ GovInfoNow plain-language explainer

AvKARE is recalling 0.5% moisturizing lubricant eye drops because of a labeling mix-up. This means the product might be confused with another type of eye drop, but there's no risk of injury or harm. Read more at govinfonow.com/recall/32354-avkare-eye-drops-label-mix-up-recall-0-5-moisturizing.

Source Summary by GovInfoNow · govinfonow.com/recall/32354-avkare-eye-drops-label-mix-up-recall-0-5-moisturizing · Updated August 17, 2026 · FDA enforcement record: FDA #D-0175-2025

Cite this page

“AvKARE Eye Drops Label Mix-Up Recall: 0.5% Moisturizing Lubricant.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32354-avkare-eye-drops-label-mix-up-recall-0-5-moisturizing. Based on FDA recall #D-0175-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0175-2025%22&limit=1).

AvKARE is voluntarily recalling Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops due to a labeling mix-up hazard, the FDA said on Dec. 18, 2024.

How to tell if you have it

Brand: AvKARE
Product: Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops
Size: 0.5 FL OZ (15 mL) bottles
NDC: 50268-068-15
Lot #: 0160
Exp. Date: April 26 2026
Quantity: 16,677 cartons
Distribution: Nationwide within the United States

The hazard

The recall involves a labeling mix-up for Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops distributed by AvKARE of Pulaski, TN.

Context

GovInfoNow's records show AvKARE has 13 other recalls on record since March 28, 2024. Recent examples include an Amantadine Capsules recall for failed dissolution specifications on Feb. 13, 2026, and a Rosuvastatin Tablets recall for dissolution issues on Dec. 31, 2025. Other recent recalls of similar products include Thea Pharma Similasan Eye Drops (April 23, 2026) and K.C. Pharmaceuticals Dry Eye Relief Eye Drops (March 3, 2026).

How to tell if you have this one

Check for the product name 'Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops' on the label. The lot number is 0160, and the expiration date is April 26, 2026.

Brand
AvKARE
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Ongoing
Distribution
Nationwide within the United States

Recall number	Product, codes & lots	Quantity	NDC
D-0175-2025	Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.; Lot #: 0160, Exp. Date April 26 2026	16,677 cartons	50268-068-15, 50268-068-02
D-0176-2025	Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15; Lot #: 0160, Exp. Date April 26 2026	0	50268-678-15

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the lot number 0160 and expiration date April 26, 2026 on the bottle.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 21 days after the firm started it.

Dec 18, 2024Firm started the recall
Jan 2, 2025FDA classified it Class III
Jan 8, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32354-avkare-eye-drops-label-mix-up-recall-0-5-moisturizing">AvKARE Eye Drops Label Mix-Up Recall: 0.5% Moisturizing Lubricant (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0175-2025 (December 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0175-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.