Recall archive / FDA drug enforcement

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, I... — FDA record D-0151-2023

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 Oct 13, 2022. 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: Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05
Reason: CGMP Deviations:
Classification: Class II
Recalling firm: Akorn, Inc.
Quantity: 121,176 bottles
Agency-reported status: Ongoing
Source record identifier: D-0151-2023

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: 1C61A, EXP 2/28/2023; 1D86A, 1D07A, EXP 3/31/2023;

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

Distribution

Nationwide in the USA

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: Jan 25, 2023
Recall initiation date: Oct 13, 2022
Center classification date: Jan 13, 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.