CLASS III Drug recall · Reported 20 Feb 2019 · FDA Enforcement Report
Cosopt Ophthalmic Solution recalled by Akorn
Akorn is recalling Cosopt Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 5% Timolol Maleate), distributed nationwide in the US. The recall was initiated on 20 Dec 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
Timeline
| 20 Dec 2018 | Recall initiated by company | |
| 8 Feb 2019 | Classified by FDA | +50 days |
| 20 Feb 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Is Cosopt Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 5% Timolol Maleate) recalled?
Yes. Akorn recalled Cosopt Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 5% Timolol Maleate) on 20 Dec 2018. The recall is Class III and its status is Terminated. Recall number D-0483-2019.
Why was it recalled?
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Which lots are affected?
Lots: 426007 and 426008, exp 4/2020
Where was it sold?
Nationwide USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Akorn
All 192| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcipotriene Topical Solution, 005% (Scalp Solution) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP 2mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |