Recall archive / FDA drug enforcement

Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Dist... — FDA record D-0265-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 30, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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.
Classification: Class III
Recalling firm: Akorn, Inc.
Quantity: 45,117 Bottles
Agency-reported status: Ongoing
Source record identifier: D-0265-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot: 081031A, Exp 2/28/2023

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the USA and Puerto Rico

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Feb 15, 2023
Recall initiation date: Jan 30, 2023
Center classification date: Feb 8, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.