Phenylephrine Hydrochloride Ophthalmic Solution — Class II drug recall D-1883-2019
Terminated recall by Akorn, Inc., reported 2019-10-09, distributed nationwide. Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee
| Recall number | D-1883-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2019-09-20 |
| Classified | 2019-09-30 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2022-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 60,176 bottles |
| Reason classes | sterility, specification failure |
| NDC | 17478-0201-15 |
| Lot numbers | 03/20, 031908A |
Product
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
Reason for recall
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
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-1883-2019. 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.