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Low RiskFDA Drug
Medications & Supplements/Topical Products

Akorn, Inc.: Sodium Chloride Ophthalmic Ointment Recalled for Metal Particulate Matter

Agency Publication Date: February 27, 2020
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Summary

Akorn, Inc. is recalling approximately 744 tubes of Sodium Chloride Ophthalmic Ointment USP, 5% sold under the Akorn, Well at Walgreens, and CVS Health brands. The recall was initiated because brown spots were found on the inside of the tubes, which were identified as particles of tin and copper from the materials used to construct the tube. These metal particles can contaminate the ointment, potentially leading to eye irritation or injury for those using the product. The affected tubes were distributed nationwide across the United States and Puerto Rico.

Risk

The presence of metal particulates like tin and copper in an eye ointment can cause physical irritation, inflammation, or injury to the surface of the eye when the product is applied.

What You Should Do

  1. Check your medicine cabinet for 3.5 g tubes of Sodium Chloride Ophthalmic Ointment USP, 5% with the brand names Akorn, Well at Walgreens, or CVS Health.
  2. For Akorn brand products (NDC 17478-622-35), check for lot numbers 8B66A (Exp 01/2021), 8C91A (Exp 02/2021), 8F07A (Exp 05/2021), 8F16A (Exp 05/2021), or 8F13A (Exp 07/2021).
  3. For Well at Walgreens brand products (NDC 0363-9050-00), check for lot number 8G59A (Exp 06/2021).
  4. For CVS Health brand products (NDC 59779-303-01), check for lot number 8G50A (Exp 06/2021).
  5. If you have an ointment from one of the affected lots, stop using it immediately and return any unused portion to the pharmacy or store where you purchased it for a refund.
  6. Contact your healthcare provider or pharmacist if you have concerns or believe you have experienced eye irritation related to this product.
  7. Contact the manufacturer, Akorn, Inc., for further instructions regarding this recall.
  8. For additional questions, you may contact the FDA Consumer Complaint hotline at 1-888-723-3332.

Your Remedy Options

๐Ÿ’ฐFull Refund

Return unused product to the pharmacy for a refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact Akorn, Inc. for further instructions.

Affected Products

Product: Sodium Chloride Ophthalmic Ointment USP, 5% (3.5 g tubes) - Akorn Brand
Model:
NDC 17478-622-35
D-0859-2020
Lot Numbers:
8B66A (Exp. 01/2021)
8C91A (Exp. 02/2021)
8F07A (Exp. 05/2021)
8F16A (Exp. 05/2021)
8F13A (Exp. 07/2021)
Date Ranges: January 2021, February 2021, May 2021, July 2021
Product: Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5% (3.5 g tubes)
Model:
NDC 0363-9050-00
D-0860-2020
Lot Numbers:
8G59A (Exp. 06/2021)
Date Ranges: June 2021
Product: CVS Health Sodium Chloride Ophthalmic Ointment USP, 5% (3.5 g tubes)
Model:
NDC 59779-303-01
D-0861-2020
Lot Numbers:
8G50A (Exp. 06/2021)
Date Ranges: June 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85018
Status: Resolved
Manufacturer: Akorn, Inc.
Sold By: Walgreens; CVS Pharmacy; Walgreen Co.; CVS Pharmacy Inc.
Manufactured In: United States
Units Affected: 2 products (720 tubes; 24 tubes)
Distributed To: Nationwide
Agency Last Updated: March 9, 2020

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.