Recall archive / FDA drug enforcement

Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactu... — FDA record D-0004-2022

Reported terminated

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 4, 2021. 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: Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
Reason: Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Classification: Class II
Recalling firm: Akorn, Inc.
Quantity: 10,210 bottles
Agency-reported status: Terminated
Source record identifier: D-0004-2022

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 0B61A, Exp 01/31/2022

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

Distribution

Distributed 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: Oct 13, 2021
Recall initiation date: Oct 4, 2021
Center classification date: Oct 7, 2021
Termination date: Aug 17, 2022

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.