Akorn, Inc. recalls Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc.
Akorn recalls Eye Itch Relief 0.035% Ketotifen Fumarate Ophthalmic Solution due to CGMP deviations. Affected units have specific NDC and lot numbers. Stop using immediately if you have this product.
Recall notice
CGMP Deviations
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling Eye Itch Relief ophthalmic solution because of manufacturing quality control issues. This recall affects specific batches sold through CVS Pharmacy. The product may not be safe for use if it was produced under improper conditions. Read more at govinfonow.com/recall/36788-akorn-eye-itch-relief-ophthalmic-solution-recall-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/36788-akorn-eye-itch-relief-ophthalmic-solution-recall-cgmp-deviations · Updated October 4, 2026 · FDA enforcement record: FDA #D-1628-2020
Cite this page
“Akorn Eye Itch Relief Ophthalmic Solution Recall: CGMP Deviations.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36788-akorn-eye-itch-relief-ophthalmic-solution-recall-cgmp-deviations. Based on FDA recall #D-1628-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1628-2020%22&limit=1).
Why it’s dangerous
CGMP deviations refer to failures in the manufacturing process that could lead to unsafe products. These deviations might result in the ophthalmic solution not meeting safety standards for eye use. The exact risk level isn't specified in the recall notice.
Who’s affected
People who own or use the recalled Eye Itch Relief ophthalmic solution with NDC 59779-920-01 and Lot 8A11A exp 12/20 are affected. Those with this specific batch are at risk due to potential manufacturing defects.
How to tell if you have this one
Check for the NDC code 59779-920-01 and lot number 8A11A on the product label. This specific batch was distributed by CVS Pharmacy in Woonsocket, RI and expires December 2020.
- Brand
Akorn- Category
Drug
What to do — step by step
Stop Using Immediately
If you have the recalled Eye Itch Relief ophthalmic solution with NDC 59779-920-01 and Lot 8A11A, stop using it right away.
Questions people ask
Is this product safe to use?
The recall states there were CGMP deviations, but does not specify if the product is safe. The manufacturer advises stopping use due to potential risks.
How can I check if my product is affected?
Check for the NDC code 59779-920-01 and lot number 8A11A on the product label. This specific batch was distributed by CVS Pharmacy in Woonsocket, RI and expires December 2020.
What should I do if I have this product?
The recall does not specify a return or disposal process. You should stop using it immediately and contact Akorn for further instructions.
Contact Akorn
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-1628-2020 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1628-2020 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1628-2020 (September 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1628-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.