Unrated Drug recall · FDA · Published December 20, 2018

Akorn Recalls COSOPT Eye Drops Due to Stability Failure

Akorn recalls specific lots of COSOPT eye drops distributed nationwide due to failed stability specifications. Check your bottle's lot number and expiration date.

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

🇺🇸 FDA recall #D-0483-2019Drug Akorn ›

Recall notice

Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.

Take action

Contact the company

Recalling firmAkorn Inc1925 W Field Ct Ste 300 · Lake Forest, IL 60045-4862

✎ GovInfoNow plain-language explainer

Akorn, Inc. is recalling COSOPT Ophthalmic Solution, USP (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate) in 10 mL dropper bottles. The recall was initiated because the product failed stability specifications, showing out-of-specification results for opalescence during a 7-month stability study. This affects lots 426007 and 426008 with an expiration date of April 2020. Read more at govinfonow.com/recall/39300-akorn-recalls-cosopt-eye-drops-due-to-stability-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/39300-akorn-recalls-cosopt-eye-drops-due-to-stability-failure · Updated October 11, 2026 · FDA enforcement record: FDA #D-0483-2019

Cite this page

“Akorn Recalls COSOPT Eye Drops Due to Stability Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39300-akorn-recalls-cosopt-eye-drops-due-to-stability-failure. Based on FDA recall #D-0483-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0483-2019%22&limit=1).

The FDA announced on Dec. 20, 2018, that Akorn Inc. voluntarily recalled COSOPT Ophthalmic Solution due to failed stability specifications. The agency issued recall number D-0483-2019 for the Class III drug distributed nationwide.

How to tell if you have it

Brand: Akorn
Product: COSOPT Ophthalmic Solution, USP (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate)
Format: 10 mL dropper bottle, Sterile
NDC: 17478-605-10
Lot codes: 426007 and 426008
Expiration date: 4/2020
Quantity: 30,794 bottles

The hazard

The recall addresses out-of-specification results for opalescence identified during a seven-month stability study. The FDA classified the issue as a Class III recall.

Context

GovInfoNow's records show Akorn, Inc. has had 64 other recalls on record since Aug. 5, 2014. Recent brand recalls include an April 26, 2023 Guaifenesin Oral Solution recall for stability issues and a Jan. 30, 2023 Atropine Sulfate Ophthalmic Solution recall for failed stability specifications. Other recent recalls of similar products include a May 18, 2026 PRED MILD Eye Drops recall due to stability issues and a Dec. 30, 2025 Fluocinolone Acetonide Solution recall for impurity risk.

How to tell if you have this one

Check your bottle for the brand name COSOPT Ophthalmic Solution, USP. Verify the NDC is 17478-605-10 and the lot number is either 426007 or 426008. The expiration date on the bottle should be 4/2020.

Brand
Akorn
Category
Drug

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide USA 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 23 months after the firm started it.

Dec 20, 2018Firm started the recall
Feb 8, 2019FDA classified it Class III
Feb 20, 2019Published in FDA’s Enforcement Report
Nov 6, 2020FDA 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/39300-akorn-recalls-cosopt-eye-drops-due-to-stability-failure">Akorn Recalls COSOPT Eye Drops Due to Stability Failure (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-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 qwen3.6:35b-a3b on October 11, 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.