# FDA recall D-0265-2023

> **Akorn, Inc.** · Class III · drug recall initiated 2023-01-30.

## 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.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0265-2023
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-01-30
- **Report date:** 2023-02-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gurnee, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0265-2023

## Citation

> AI Analytics. FDA recall D-0265-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-0265-2023. Source: US FDA. Licensed CC0.

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