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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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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...
Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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
Supplements·0 affected·Apr 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 Drugs·0 affected·Apr 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...
Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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,...
Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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...
Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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
Drugs·0 affected·Apr 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,...
Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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...
Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·0 affected·Apr 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 Drugs·45,117 affected·Jan 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 Drugs·91,692 affected·Oct 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...
Drugs·2,369,258 affected·Oct 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 Drugs·65,006 affected·Oct 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 Drugs·196,254 affected·Oct 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 Drugs·3,108 affected·Oct 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 Drugs·314,543 affected·Oct 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 Drugs·2,095,068 affected·Oct 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 Drugs·173,928 affected·Oct 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 Drugs·524,506 affected·Oct 13, 2022