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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Over-the-Counter

AvKARE Moisturizing Lubricant Eye Drops Recalled for Label Mix-Up

Agency Publication Date: January 2, 2025
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Summary

AvKARE is recalling approximately 16,677 cartons of two types of moisturizing eye drops: Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% and Polyvinyl Alcohol Ophthalmic Solution 1.4%. The recall was issued because the labels for these two different eye drop products were mixed up. Consumers should look for 15 mL bottles labeled with lot number 0160 and an expiration date of April 26, 2026.

Risk

Because of the label mix-up, consumers may unknowingly use the wrong eye drop solution. This could lead to ineffective treatment of dry eye symptoms or minor eye irritation. No injuries or adverse reactions have been reported to date.

What You Should Do

  1. This recall affects AvKARE brand Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (NDC 50268-068-15) and Polyvinyl Alcohol Ophthalmic Solution 1.4% (NDC 50268-678-15) Lubricant Eye Drops sold in 15 mL bottles. Affected units are marked with lot number 0160 and an expiration date of April 26, 2026.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact AvKARE for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops (15 mL)by AvKARE
Variants: 0.5% Strength, Ophthalmic Solution
Lot Numbers:
0160 (Exp April 26 2026)
NDC:
50268-068-15

Distributed by AvKARE, Pulaski, TN.

Product: Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops (15 mL)by AvKARE
Variants: 1.4% Strength, Ophthalmic Solution
Lot Numbers:
0160 (Exp April 26 2026)
NDC:
50268-678-15

Distributed by AvKARE, Pulaski, TN.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96032
Status: Active
Manufacturer: AvKARE
Sold By: Pharmacies and drug stores nationwide
Manufactured In: United States
Units Affected: 2 products (16,677 cartons; 0)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.