Brand
Akorn, Inc. Recalls
192 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Akorn, Inc..
192Total Recalls
0Critical
18.8MUnits Affected
Apr 26, 2023Most Recent
All Recalls
Every Akorn, Inc. Recall
Sorted by most recent. Click any recall for full details.
192 recalls
High RiskFDA
Akorn, Inc.
Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Ophthalmic Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031...
Oral Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Oral Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, St...
Injectable Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lak...
Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurn...
Ophthalmic Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Supplements0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Oral Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031...
Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurn...
Oral Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake ...
Injectable Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Ophthalmic Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee,...
Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. AL...
Ophthalmic Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031....
Oral Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company-...
Oral Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Man...
Ophthalmic Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. A...
Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx On...
Oral Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Ep...
Injectable Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Oral Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Ophthalmic Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest...
Topical Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company,...
Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Injectable Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031...
Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurn...
Ophthalmic Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ...
Oral Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Inhaled / Nasal Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Ophthalmic Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs
Inhaled / Nasal Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufactured by: Akorn,...
Injectable Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn, Inc., L...
Injectable Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
Topical Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, I...
Injectable Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, ...
Topical Drugs0 affectedApr 26, 2023
High RiskFDA
Akorn, Inc.
Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx onl...
Ophthalmic Drugs0 affectedApr 26, 2023
RecallFDA
Akorn, Inc.
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Op...
Topical Drugs45,117 affectedJan 30, 2023
High RiskFDA
Akorn, Inc.
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by...
Ophthalmic Drugs91,692 affectedOct 13, 2022
High RiskFDA
Akorn, Inc.
Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 1747...
Drugs2,369,258 affectedOct 13, 2022
High RiskFDA
Akorn, Inc.
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: M...
Ophthalmic Drugs65,006 affectedOct 13, 2022
High RiskFDA
Akorn, Inc.
GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examination...
Ophthalmic Drugs196,254 affectedOct 13, 2022
High RiskFDA
Akorn, Inc.
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
Ophthalmic Drugs3,108 affectedOct 13, 2022
High RiskFDA
Akorn, Inc.
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 174...
Ophthalmic Drugs314,543 affectedOct 13, 2022
High RiskFDA
Akorn, Inc.
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 1...
Ophthalmic Drugs2,095,068 affectedOct 13, 2022
High RiskFDA
Akorn, Inc.
Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 1...
Ophthalmic Drugs173,928 affectedOct 13, 2022
High RiskFDA
Akorn, Inc.
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ND...
Topical Drugs524,506 affectedOct 13, 2022