thejoe Akorn, Inc.

Akorn, Inc.: 192 FDA recall reports

Every drug recall the FDA has published for Akorn, Inc.. The fault, and how the agency graded it.

192Reports

0Class I

118Ongoing

2023-06-07Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	155
Class III	37

By year reported

Year	Reports
2014	1
2015	11
2016	8
2017	6
2018	11
2019	14
2020	9
2021	5
2022	13
2023	114

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 m

D-0818-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Di

D-0794-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 6

D-0820-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC

D-0864-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL

D-0790-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045.

D-0844-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactur

D-0787-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL

D-0817-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Compan

D-0792-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating C

D-0786-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC.,

D-0821-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Comp

D-0827-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC,

D-0803-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Co

D-0785-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., L

D-0860-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC.

D-0795-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed

D-0841-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distribute

D-0802-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by:

D-0863-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles

D-0779-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthal

D-0788-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Fores

D-0825-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Ma

D-0830-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest

D-0797-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc

D-0812-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating

D-0857-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn

D-0861-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles,

D-0819-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by

D-0799-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operati

D-0800-2023 · Class II · reported 2023-06-07 · Ongoing

Why it was recalled: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product: Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Where it went: Nationwide in the USA and Puerto Rico
How much: N/A

Showing the 30 most recent of 192. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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