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 per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed b...
Ophthalmic Drugs·121,176 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, In...
Topical Drugs·36,455 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lak...
Ophthalmic Drugs·6,273 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn,...
Ophthalmic Drugs·1,752 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045...
Ophthalmic Drugs·23,026 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Ako...
Topical Drugs·2,082 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: ...
Ophthalmic Drugs·51,601 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured ...
Topical Drugs·36,025 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60...
Topical Drugs·1,109,600 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17...
Ophthalmic Drugs·1,310,324 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-2...
Ophthalmic Drugs·188,550 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ...
Ophthalmic Drugs·31,073 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest...
Topical Drugs·1,164,171 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn,...
Ophthalmic Drugs·967,075 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL...
Ophthalmic Drugs·1,584 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 1747...
Ophthalmic Drugs·2,563 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn,...
Ophthalmic Drugs·163,996 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC...
Ophthalmic Drugs·267,678 affected·Oct 13, 2022
High RiskFDA
Akorn, Inc.
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
Oral Drugs·18,145 affected·Sep 21, 2022
High RiskFDA
Akorn, Inc.
Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61...
Oral Drugs·177,439 affected·Sep 21, 2022
High RiskFDA
Akorn, Inc.
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
Drugs·82,689 affected·Aug 31, 2022
High RiskFDA
Akorn, Inc.
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478...
Topical Drugs·48,636 affected·Aug 31, 2022
RecallFDA
Akorn, Inc
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Fore...
Ophthalmic Drugs·5,226 affected·Aug 8, 2022
High RiskFDA
Akorn, Inc
PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Oral Drugs·14,712 affected·Aug 1, 2022
High RiskFDA
Akorn, Inc.
Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL...
Inhaled / Nasal Drugs·44,400 affected·Jun 13, 2022
High RiskFDA
Akorn, Inc.
Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC.,...
Topical Drugs·2,736 affected·Jun 10, 2022
RecallFDA
Akorn, Inc.
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. ...
Oral Drugs·66,744 affected·Apr 15, 2022
High RiskFDA
Akorn, Inc.
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit...
Injectable Drugs·31,510 affected·Jan 5, 2022
RecallFDA
Akorn, Inc.
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- ND...
Oral Drugs·10,836 affected·Dec 3, 2021
RecallFDA
Akorn, Inc.
Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc.,...
Oral Drugs·8,184 affected·Dec 3, 2021
High RiskFDA
Akorn, Inc.
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc.,...
Ophthalmic Drugs·10,210 affected·Oct 4, 2021
High RiskFDA
Akorn, Inc.
TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A...
Ophthalmic Drugs·62,331 affected·Sep 8, 2021
High RiskFDA
Akorn, Inc.
Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-...
Drugs·264 affected·Aug 13, 2021
High RiskFDA
Akorn, Inc.
Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, ...
Topical Drugs·142,188 affected·Aug 2, 2021
High RiskFDA
Akorn, Inc.
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech...
Oral Drugs·8,183 affected·Mar 8, 2021
High RiskFDA
Akorn, Inc.
Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-2...
Oral Drugs·22,248 affected·Dec 28, 2020
High RiskFDA
Akorn, Inc.
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, ND...
Ophthalmic Drugs·25,843 affected·Sep 3, 2020
RecallFDA
Akorn, Inc.
Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: ...
Oral Drugs·17,424 affected·Jun 5, 2020
RecallFDA
Akorn Inc
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lak...
Injectable Drugs·15,170 affected·Mar 25, 2020
RecallFDA
Akorn, Inc.
Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60...
Topical Drugs·24 affected·Feb 21, 2020
RecallFDA
Akorn, Inc.
CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 0289...
Topical Drugs·0 affected·Feb 21, 2020
RecallFDA
Akorn, Inc.
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
Topical Drugs·720 affected·Feb 21, 2020
RecallFDA
Akorn, Inc.
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake...
Ophthalmic Drugs·33,343 affected·Dec 26, 2019
High RiskFDA
Akorn Inc
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC ...
Drugs·16,078 affected·Dec 16, 2019
High RiskFDA
Akorn, Inc.
MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: ...
Oral Drugs·4,206 affected·Nov 15, 2019
High RiskFDA
Akorn, Inc.
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478...
Ophthalmic Drugs·60,176 affected·Sep 20, 2019
High RiskFDA
Akorn, Inc.
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
Drugs·10,543 affected·Sep 17, 2019
RecallFDA
Akorn, Inc.
Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc...
Injectable Drugs·4,085 affected·Aug 6, 2019