Atropine Sulfate Ophthalmic 1% Solution — Class III drug recall D-0577-2018
Terminated recall by Akorn, Inc., reported 2018-03-14, distributed nationwide. Failed Stability Specification: OOS low viscosity results discovered during retain testing.
| Recall number | D-0577-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2018-02-21 |
| Classified | 2018-03-05 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2020-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 31,812 bottles |
| Reason classes | specification failure |
| NDC | 17478-0215-05 |
| Lot numbers | 011037A |
Product
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
Reason for recall
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
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-0577-2018. 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.