Betaxolol ophthalmic solution recalled for manufacturing process violations
Akorn, Inc. is voluntarily recalling Betaxolol ophthalmic solution (6,273 bottles, lot 1A08A, exp. 12/31/2022) due to manufacturing deviations. Consumers should consult their healthcare provider.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a sterile ophthalmic solution due to manufacturing practice deviations, which represents a risk-of-harm product. No illnesses or injuries have been reported, and the potential harm is theoretical, placing it at the upper bound of moderate-to-high severity per the rubric.
Plain-English summary
Akorn, Inc. is voluntarily recalling Betaxolol Ophthalmic Solution, USP 0.5%, a prescription eye drop medication supplied in 5 mL bottles. The recall encompasses 6,273 bottles with lot number 1A08A and expiration date of December 31, 2022.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process. These deviations may impact the quality and safety characteristics of the product.
The affected medication was distributed nationwide in the United States. Patients and healthcare providers who have bottles from this lot should take appropriate action.
Consumers should not use bottles from lot 1A08A and should consult their healthcare provider regarding alternative treatment options or proper disposal of the medication.
The recalled product
- Product
- Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 6,273
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 1A08A
- EXP 12/31/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 27 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 27 products in this recall →Related recalls
Same manufacturer · Akorn, Inc.
See all →- HighTobramycin Ophthalmic Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighGuaifenesin Oral Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighFDA Recalls Calcitriol Injection Due to Manufacturing Practice Violations
FDA (Drugs) · 2023-06-07
- HighAkorn Hydromorphone Hydrochloride Injection Recalled Due to CGMP Deviations
FDA (Drugs) · 2023-06-07
- HighMidazolam Injection Recalled Due to Manufacturing Compliance and Stability Study Issues
FDA (Drugs) · 2023-06-07
Same hazard · contamination
See all →- SevereEthicon Recalls Silk Surgical Sutures Packaged with Alcohol-Based Fluid
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- SevereBetaxolol Ophthalmic Solution Recalled for Sterility Failure
FDA (Drugs) · 2021-10-13
- LowAkorn Recalls Atropine Sulfate Ophthalmic Solution Due to Viscosity Failure
FDA (Drugs) · 2018-03-14
- HighFDA Recalls Apraclonidine Ophthalmic Solution Due to Manufacturing Compliance Failures
FDA (Drugs) · 2023-06-07
- HighLevofloxacin Ophthalmic Solution Recalled Due to Manufacturing Practice Deviations
FDA (Drugs) · 2023-06-07
- SevereAkorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Impurities
FDA (Drugs) · 2019-03-20
- LowAkorn Recalls Azelastine HCl Ophthalmic Solution Due to Impurities
FDA (Drugs) · 2018-09-05