Akten
Generic name: lidocaine hydrochloride anhydrous · Brand names: Akten
Class II recall · Ongoing
Lack of Assurance of Sterility
Posted May 12, 2026. Check lot numbers with your pharmacy before taking Akten. View FDA recall notices.
Information sourced from FDA Structured Product Labeling, updated April 23, 2026.
What is it used for?
1- INDICATIONS AND USAGE AKTEN is indicated for ocular surface anesthesia during ophthalmologic procedures in adults and pediatric patients. AKTEN is an amide local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures.
How to take it
The recommended dose of AKTEN is 2 drops applied to the ocular surface in the area of the planned procedure. AKTEN may be reapplied to maintain anesthetic effect. The recommended dose of AKTEN is 2 drops applied to the ocular surface in the area of the planned procedure. AKTEN may be reapplied to maintain anesthetic effect.
Warnings
For Topical Ophthalmic Use: AKTEN is not for injection or intraocular administration. Patients should not touch the eye for at least 10 to 20 minutes after using AKTEN as accidental injuries can occur due to insensitivity of the eye. Corneal Opacification: Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. For Administration by Healthcare Provider: AKTEN is not intended for patient self-administration.
For Topical Ophthalmic Use
AKTEN is not for injection or intraocular administration.
Corneal Injury Due to Insensitivity Patients
should not touch the eye for at least 10 to 20 minutes after using AKTEN as accidental injuries can occur due to insensitivity of the eye.
Corneal Opacification Prolonged
use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.
For Administration by Healthcare Provider
AKTEN is indicated for administration under the direct supervision of a healthcare provider. AKTEN is not intended for patient self-administration.
Who should not take it
None. None.
Pregnancy
Pregnancy Risk Summary There
are no adequate and well-controlled studies with AKTEN in pregnant women to inform a drug-associated risk. In animal reproduction studies, subcutaneous administration of lidocaine to pregnant rats at doses >800-fold the human dose based on body surface area did not result in adverse developmental effects. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Side effects
Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation. Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation. To report SUSPECTED ADVERSE REACTIONS, contact Thea Pharma Inc. at 1-833-838-4028 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
All information on this site is provided “as-is” for informational purposes only and is not a substitute for medical advice or treatment. You should consult with a medical professional if you have any questions about your health. Source: FDA Structured Product Labeling.