Recall archive / FDA drug enforcement

Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL... — FDA record D-0805-2023

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 Apr 26, 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: Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Classification: Class II
Recalling firm: Akorn, Inc.
Quantity: N/A
Agency-reported status: Ongoing
Source record identifier: D-0805-2023

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Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	All Lots

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: Jun 7, 2023
Recall initiation date: Apr 26, 2023
Center classification date: Jun 1, 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.