LATANOPROST OPHTHALMIC SOLUTION — Class II drug recall D-0661-2017
Terminated recall by Akorn, Inc., reported 2017-04-19, distributed nationwide. Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
| Recall number | D-0661-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2017-03-17 |
| Classified | 2017-04-11 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2019-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 107,940 bottles |
| Reason classes | sterility, packaging |
| NDC | 17478-0625-12 |
| Lot numbers | 11/17, 12/17, 6/17, 8/17, LAB11G52, LAB15G52, LAB18I52, LAB1A62, LAB9A62, LAB9L52 |
Product
LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
Reason for recall
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
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-0661-2017. 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.