Atropine Sulfate Ophthalmic Solution — Class III drug recall D-0265-2023
Ongoing recall by Akorn, Inc., reported 2023-02-15, distributed nationwide. Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M sta
| Recall number | D-0265-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Gurnee, IL, United States |
| Recall initiated | 2023-01-30 |
| Classified | 2023-02-08 |
| Reported by FDA | 2023-02-15 |
| Distributed | Nationwide (US) |
| Quantity | 45,117 bottles |
| Reason classes | specification failure |
| NDC | 17478-0215-02 |
| Lot numbers | 081031A |
| Expiration dates | 2023-02-28 |
Product
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
Reason for recall
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
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-0265-2023. 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.