Use caution Drug recall · FDA · Published February 21, 2020

Akorn Well at Walgreens Ophthalmic Ointment Recall: Brown Spots Risk

Akorn recalls Well at Walgreens Sodium Chloride Ophthalmic Ointment USP 5% 3.5g tubes due to brown spots inside tubes. Brown spots may cause eye injury. Stop using and contact Walgreens.

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

🇺🇸 FDA recall #D-0860-2020Drug Akorn ›

Use caution until it’s fixed

Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.

Take action

Contact the company

Recalling firmAkorn, Inc.1925 W Field Ct Ste 300 · Lake Forest, IL 60045-4862

✎ GovInfoNow plain-language explainer

Akorn is recalling Well at Walgreens Sodium Chloride O: 5% Ophthalmic Ointment USP 3.5g tubes because brown spots inside the tubes could cause eye injury. This recall affects products distributed by Walgreens with specific lot numbers and expiration dates. Read more at govinfonow.com/recall/37367-akorn-well-at-walgreens-ophthalmic-ointment-recall-brown-spots-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37367-akorn-well-at-walgreens-ophthalmic-ointment-recall-brown-spots-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0860-2020

Cite this page

“Akorn Well at Walgreens Ophthalmic Ointment Recall: Brown Spots Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37367-akorn-well-at-walgreens-ophthalmic-ointment-recall-brown-spots-risk. Based on FDA recall #D-0860-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0860-2020%22&limit=1).

The FDA announced on Feb. 21, 2020, that Akorn, Inc. voluntarily recalled Well at Walgreens Sodium Chloride Ophthalmic Ointment USP due to the presence of brown particulate matter inside the tubes. Consumers should return the product to the place of purchase for a refund.

How to tell if you have it

Brand: Akorn
Product: Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes
NDC: 0363-9050-00
Lot #: 8G59A
Expiration Date: 06/2021
Distributed by: Walgreen Co.
Distribution: Nationwide within United States and Puerto Rico

The hazard

The recall is due to brown spots observed on the inside of the tube, identified as tin with trace copper, which are the base materials of construction for the tube. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Akorn, Inc. has 64 other recalls on record since Aug. 5, 2014. Other recent recalls include an Akorn Guaifenesin Oral Solution recall on April 26, 2023, and an Akorn Atropine Sulfate Ophthalmic Solution recall on Jan. 30, 2023. Similar products have faced issues, such as a Dabur Circle K Antibiotic Ointment recall on June 2, 2026, and a Lupin prednisolone acetate ophthalmic suspension recall on June 4, 2026.

How to tell if you have this one

Check for brown spots inside the tube. The product has a lot number starting with 8G59A and expires by June 2021. It was sold by Walgreens at specific locations.

Brand
Akorn
Category
Drug

FDA recall event · 3 products

All 3 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
Terminated
Distribution
Nationwide within United States and Puerto Rico

Recall number	Product, codes & lots	Quantity
D-0859-2020	Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35; Lot #: 8B66A, Exp. Date 01/2021; Lot 8C91A, Exp. Date 02/2021; Lots 8F07A, 8F16A, Exp. Date 05/2021; Lot 8F13A, Exp. Date 07/2021.	720 tubes
D-0860-2020	Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.; Lot #:8G59A, Exp. Date 06/2021	24 tubes
D-0861-2020	CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01; Lot #:8G50A, Exp. Date 06/2021	N/A

Based on the official FDA remedy

What to do — step by step

Stop Using Now
Discard the product immediately if you see brown spots inside the tube.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Feb 21, 2020Firm started the recall
Feb 27, 2020FDA classified it Class III
Mar 4, 2020Published in FDA’s Enforcement Report
Jul 28, 2022FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/37367-akorn-well-at-walgreens-ophthalmic-ointment-recall-brown-spots-risk">Akorn Well at Walgreens Ophthalmic Ointment Recall: Brown Spots Risk (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-0860-2020 (February 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0860-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.