Skip to main content
COVID-19

Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown

On April 26, 2023, Akorn Operating Company LLC has initiated a voluntary recall of various within-expiry human products as a result of the closures and discontinuation of the Quality activities of these marketed products. The discontinuation of the Quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately. Akorn has not received any reports of adverse events related to this recall.

Product Lot
Acetaminophen & Codeine Phosphate Oral Solution 120mg & 12mg/5mL All NDCs and All Lots
Acetic Acid Otic Solution All NDCs and All Lots
Acyclovir Oral Suspension, 200mg/5mL All NDCs and All Lots
Albuterol Sulfate Syrup, 2mg (base) All NDCs and All Lots
Amantadine HCl Syrup, USP 50 mg per 5mL All NDCs and All Lots
Apraclonidine Ophthalmic Solution 0.5% All NDCs and All Lots
Artificial Tears All NDCs and All Lots
Atropine Sulfate Ophthalmic Solution All NDCs and All Lots
Azelastine Hydrochloride Nasal Spray, 0.1% All NDCs and All Lots
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, 3.5g All NDCs and All Lots
Calcipotriene Scalp Solution, 0.005% All NDCs and All Lots
Calcitriol Injection 1 mcg and 2 mcg All NDCs and All Lots
Cetrorelix Acetate for Injection, 0.25 mg/vial, Single-Dose Vial All NDCs and All Lots
Ciclopirox Topical Solution 8% All NDCs and All Lots
Cimetidine HCl Oral Solution All NDCs and All Lots
Clobetasol Propionate Cream 0.05% All NDCs and All Lots
Clobetasol Propionate Ointment, 0.05% All NDCs and All Lots
Clobetasol Propionate Shampoo, 0.05% All NDCs and All Lots
Cromolyn Sodium Ophthalmic Solution 4% All NDCs and All Lots
Detomidine Hydrochloride 20mL and 5mL All NDCs and All Lots
Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) All NDCs and All Lots
Diuril® (chlorothiazide sodium) Injection All NDCs and All Lots
DOCU LIQUID- docusate sodium liquid All NDCs and All Lots
Ephedrine Injection 50 mg/mL All NDCs and All Lots
Ferrous Sulfate Elixir and Iron Supplement All NDCs and All Lots
Fluticasone Propionate Nasal Spray All NDCs and All Lots
Gonak Hypromellose Ophth Sol All NDCs and All Lots
Granisetron HCl Injection 1 mg/mL All NDCs and All Lots
Guaifenesin and Codeine Phosphate Liquid All NDCs and All Lots
HydrALAZINE HCl Injection All NDCs and All Lots
Hydrocortisone and Acetic Acid Otic Solution All NDCs and All Lots
Hydromorphone High Potency Injection USP – Ampule and Vial All NDCs and All Lots
IC-Green Sterile Indocyanine Green Injection USP All NDCs and All Lots
Ketorolac Tromethamine Ophthalmic Solution, 0.5% All NDCs and All Lots
Lactulose Syrup (Oral) and (Oral/Rectal) All NDCs and All Lots
Levetiracetam Injection USP, 500 mg/5 mL (100 mg/mL) single-dose vial All NDCs and All Lots
Levocarnitine Oral Solution, USP All NDCs and All Lots
Levofloxacin Injection, 25 mg/mL All NDCs and All Lots
Levofloxacin Oral Solution All NDCs and All Lots
Levofloxacin Opth Solution All NDCs and All Lots
Lidocaine 2.5% & Prilocaine 2.5% Cream All NDCs and All Lots
Lidocaine Ointment All NDCs and All Lots
Lidocaine HCl Jelly USP, 2% All NDCs and All Lots
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% All NDCs and All Lots
Lorazepam Injection 2 mg/mL vial All NDCs and All Lots
Lorazepam Oral Concentrate, 2mg All NDCs and All Lots
Megestrol Acetate Oral Suspension 40 mg/mL All NDCs and All Lots
Midazolam Injection USP 1 mg/mL & 5 mg/mL - vial All NDCs and All Lots
Moxifloxacin HCl Solution 0.5% All NDCs and All Lots
Naloxone Injection 0.4 mg/mL; 1 mL and 10mL Vial All NDCs and All Lots
Neomycin & Polymyxin B Sulfates & Bacitracin Zinc Ophthalmic Ointment All NDCs and All Lots
Olopatadine HCl Nasal Spray, 665 mcg/spray All NDCs and All Lots
Olopatadine Solution 0.1% and 0.2% All NDCs and All Lots
Oxcarbazepine Oral Suspension USP, 300 mg/5 mL All NDCs and All Lots
Pilocarpine 1, 2, & 4% All NDCs and All Lots
Prednisolone Sodium Phosphate Oral Solution All NDCs and All Lots
Promethazine HCl & Codeine Phosphate Oral Solution All NDCs and All Lots
Promethazine HCl Oral Solution All NDCs and All Lots
Proparacaine HCl Ophthalmic Solution, 0.5% All NDCs and All Lots
Rifampin Capsules USP, 150 mg & 300 mg All NDCs and All Lots
Ropivacaine Hydrochloride Injection USP, 0.2% and 5mg/mL All NDCs and All Lots
Fentanyl Citrate Injection All NDCs and All Lots
Sodium Chloride Ophthalmic Ointment All NDCs and All Lots
Sodium Chloride Solution Drops All NDCs and All Lots
Sodium DIURIL All NDCs and All Lots
Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL All NDCs and All Lots
Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL All NDCs and All Lots
Timolol Maleate Ophthalmic Solution 0.5%, 2.5, 5, 10, & 15mL All NDCs and All Lots
Tobramycin Inhalation Solution USP, 300 mg/5 mL All NDCs and All Lots
Tobramycin Ophthalmic Solution 0.3% All NDCs and All Lots
Trihexyphenidyl HCl Oral Sol All NDCs and All Lots
Tropicamide Ophthalmic Solution 0.5% and 1% All NDCs and All Lots
Valproic Acid Oral Solution All NDCs and All Lots
Vitamin D Suppl. Drops 50mL All NDCs and All Lots
XOPENEX- levalbuterol hydrochloride solution, concentrate All NDCs and All Lots

Consumers with questions regarding this recall can contact Akorn at (800) 932-5676, Monday – Friday, 8am – 5pm CDT.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Source:

  1. FDA MedWatch. “Recalls, Market Withdrawals, & Safety Alerts”. Retrieved May 1, 2023 from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/akorn-issues-voluntary-nationwide-recall-various-human-and-animal-drug-products-within-expiry-due?utm_medium=email&utm_source=govdelivery
Published on: May 8, 2023, 03:21 a.m. ET
Last updated on: June 1, 2023, 00:47 a.m. ET