FDA Drug recall D-0265-2023
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Oper…
- FDA Drug
- Class III
- ongoing
- Published 2023-02-15
On 2023-02-15 the FDA classified a Class III recall of Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Oper… by Akorn, citing failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0265-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-01-30 |
| Published | 2023-02-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
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
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Identifiers
| code_info | Lot: 081031A, Exp 2/28/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0265-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.