COSOPT Ophthalmic Solution — Class III drug recall D-0483-2019
Terminated recall by Akorn Inc, reported 2019-02-20, distributed nationwide. Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
| Recall number | D-0483-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn Inc, Lake Forest, IL, United States |
| Recall initiated | 2018-12-20 |
| Classified | 2019-02-08 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2020-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 30,794 bottles |
| Reason classes | specification failure |
| NDC | 17478-0605-10 |
| Lot numbers | 426007, 426008 |
| Expiration dates | 2020-04 |
Product
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
Reason for recall
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0483-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.