Akorn Inc recalls COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile,
Akorn recalls 10mL COSOPT Ophthalmic Solution bottles with specific lot numbers due to stability problems affecting product quality.
Lower-risk recall
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling certain COSOPT eye drops because they failed stability tests. This means the product may not be safe for use after the expiration date. Read more at govinfonow.com/recall/39300-akorn-cosopt-ophthalmic-solution-recall-stability-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/39300-akorn-cosopt-ophthalmic-solution-recall-stability-issues · Updated October 5, 2026 · FDA enforcement record: FDA #D-0483-2019
Cite this page
“Akorn COSOPT Ophthalmic Solution Recall: Stability Issues.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39300-akorn-cosopt-ophthalmic-solution-recall-stability-issues. Based on FDA recall #D-0483-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0483-2019%22&limit=1).
Why it’s dangerous
The eye drops failed stability tests, showing changes in appearance (opalescence) after 7 months. This could mean the medication might not work properly or could be unsafe after the expiration date.
Who’s affected
People who have the specific lot numbers (426007 and 426:008) of the 10mL COSOPT eye drops. Those with prescription for this medication are most at risk.
How to tell if you have this one
Check the product label for the lot numbers 426007 or 426008 on the 10mL dropper bottle. The product is prescription-only and expires April 2020.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Label
Look for lot numbers 426007 or 426008 on the 10mL dropper bottle.
Questions people ask
Is this product safe to use?
The product failed stability tests and may not be safe after the expiration date. Consult your doctor for advice.
What should I do with the recalled product?
The recall record does not specify a remedy, so contact your doctor for guidance.
How can I tell if I have the recalled product?
Check the product label for lot numbers 426007 or 426008 on the 10mL dropper bottle.
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-0483-2019 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0483-2019 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-0483-2019 (December 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0483-2019 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.