Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 25, 2023DrugsFDA
Akorn, Inc. recalls Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake For
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Oper
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only,
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufac
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, I
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufac
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Fo
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045;
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manu
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 6
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL droppe
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinos
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactu
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., L
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 600
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc.
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by:
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufa
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn,
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Steri
Hazard: CGMP Deviations:
October 5, 2022DrugsFDA
Akorn, Inc. recalls Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-cou
Hazard: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
October 5, 2022DrugsFDA
Akorn, Inc. recalls Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031
Hazard: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
September 14, 2022DrugsFDA
Akorn, Inc. recalls Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL
Hazard: cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
September 14, 2022DrugsFDA
Akorn, Inc. recalls Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045
Hazard: cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
September 7, 2022DrugsFDA
Akorn, Inc recalls Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn
Hazard: Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
August 24, 2022DrugsFDA
Akorn, Inc recalls PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 1170
Hazard: Defective Container: Product has incomplete induction seals.