Proparacaine Hydrochloride Ophthalmic Solution — Class III drug recall D-1388-2020
Terminated recall by Akorn, Inc., reported 2020-07-22, distributed nationwide. Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
| Recall number | D-1388-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2019-12-26 |
| Classified | 2020-07-14 |
| Reported by FDA | 2020-07-22 |
| Terminated | 2022-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 33,343 bottles |
| Reason classes | chemical contamination, specification failure |
| NDC | 17478-0263-12 |
| Lot numbers | 9E52A |
| Expiration dates | 2021-04 |
Product
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
Reason for recall
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
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-1388-2020. 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.