Manufacturer

Akorn, Inc.

128 recalls in our database name Akorn, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 128

HighFDA (Drugs)·D-0836-2023·2023-06-07
Prednisolone Oral Solution Recalled Due to Manufacturing Standards Deviation
Akorn, Inc. is recalling all lots of Prednisolone Oral Solution 15 mg/5 mL due to a manufacturing standards deviation. The company discontinued required stability studies after ceasing operations.
Product
Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0827-2023·2023-06-07
Megestrol Acetate Oral Suspension Recalled for Incomplete Stability Studies
Akorn recalled all lots of Megestrol Acetate Oral Suspension nationwide due to the firm's inability to complete required stability studies after ceasing operations.
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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0809-2023·2023-06-07
HydrALAZINE Injection Recalled Due to Manufacturing Deviations and Unverified Stability
Akorn, Inc. recalled all lots of HydrALAZINE HCl Injection nationwide because the manufacturer ceased operations and could no longer conduct required stability studies.
Product
HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0816-2023·2023-06-07
Levetiracetam Oral Solution Recalled Nationwide for Incomplete Stability Testing
Akorn, Inc. is recalling Levetiracetam Oral Solution nationwide after closing and failing to complete required FDA stability studies. The Class II recall affects all lots distributed in the United States and Puerto Rico.
Product
Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0812-2023·2023-06-07
FDA Recalls IC-Green Injectable Drug: Manufacturing Deviations Prevent Stability Verification
Akorn, Inc. recalled all lots of IC-Green injectable drug nationwide because the firm went out of business and could not complete stability studies required to verify manufacturing compliance.
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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0820-2023·2023-06-07
Levofloxacin Ophthalmic Solution Recalled Due to Manufacturing Practice Deviations
Akorn, Inc. is recalling all lots of Levofloxacin Ophthalmic Solution 0.5% due to manufacturing practice deviations. The firm went out of business and could not continue required stability studies.
Product
Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0790-2023·2023-06-07
FDA Recalls Calcitriol Injection Due to Manufacturing Practice Violations
FDA is recalling all lots of Calcitriol Injection 1 mcg/mL due to current good manufacturing practice (CGMP) violations. The manufacturer went out of business and could not complete required stability studies.
Product
Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0800-2023·2023-06-07
Diuril Injectable Drug Recalled Due to Manufacturing Quality Deviations
Akorn, Inc. is recalling all lots of Diuril (chlorothiazide sodium) Injection, 500mg/vial, distributed nationwide, due to manufacturing deviations. The manufacturer went out of business and was unable to complete required 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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0815-2023·2023-06-07
Lactulose Solution Recall Due to Manufacturing Practice Deviations
Akorn, Inc. has recalled all lots of Lactulose Solution, USP 30 mL Unit Dose Cups nationwide due to the company's inability to continue stability studies after ceasing operations.
Product
Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0818-2023·2023-06-07
Levofloxacin Injection Nationwide Recall Due to Manufacturing Deviations
Akorn, Inc. has recalled all lots of Levofloxacin Injection nationwide due to manufacturing process violations and inability to complete required 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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0860-2023·2023-06-07
Prescription eye solution recalled due to discontinued stability studies
Akorn, Inc. is recalling all lots of Olopatadine HCl ophthalmic solution 0.2% because the company went out of business and can no longer conduct required stability testing.
Product
Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0810-2023·2023-06-07
Hydrocortisone and Acetic Acid Otic Solution Recalled Due to Manufacturing Deviations
Akorn, Inc. is recalling all lots of Hydrocortisone and Acetic Acid Otic Solution, USP (10 mL bottles) nationwide due to manufacturing deviations. The company ceased business and could not complete required stability studies to verify product quality.
Product
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0863-2023·2023-06-07
Ropivacaine Hydrochloride Injection recalled; manufacturer unable to complete stability studies
Akorn, Inc. recalls all lots of Ropivacaine Hydrochloride Injection nationwide because the manufacturer went out of business and cannot complete required 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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0830-2023·2023-06-07
Naloxone Injection Recall Due to Manufacturing Process Deviations
Akorn, Inc. is recalling all lots of Naloxone Injection 0.4 mg/mL due to manufacturing process deviations. The manufacturer could not complete required 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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0861-2023·2023-06-07
Pilocarpine Hydrochloride Ophthalmic Solution Recall Due to Manufacturing Deviations
Akorn Inc. is recalling all lots of Pilocarpine Hydrochloride Ophthalmic Solution 2% due to manufacturing deviations that prevented completion of stability studies. The product was distributed nationwide in the USA and Puerto Rico.
Product
Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0843-2023·2023-06-07
Fentanyl Citrate Injection Nationwide Recall Due to Manufacturing Compliance Deviations
Akorn, Inc. is recalling all lots of Fentanyl Citrate Injection nationwide due to manufacturing compliance deviations. The company was unable to complete required stability studies after ceasing operations.
Product
Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0804-2023·2023-06-07
Fluticasone Propionate Nasal Spray Recalled Due to Manufacturing Quality Concerns
Akorn, Inc. is recalling all lots of Fluticasone Propionate Nasal Spray, 50mcg due to manufacturing deviations and inability to verify product stability.
Product
Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0784-2023·2023-06-07
FDA Recalls Apraclonidine Ophthalmic Solution Due to Manufacturing Compliance Failures
Akorn Inc. is recalling all lots of Apraclonidine Ophthalmic Solution 0.5% due to manufacturing compliance deviations. The firm went out of business and could not complete required stability studies.
Product
Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0823-2023·2023-06-07
Lidocaine HCl Jelly 2% recalled nationwide for manufacturing compliance deviations
Akorn, Inc. is recalling all lots of Lidocaine HCl Jelly USP 2% in 5mL tubes nationwide due to manufacturing quality control violations. The company ceased operations and could not complete required stability testing.
Product
Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0786-2023·2023-06-07
FDA Recalls All Lots Akorn Artificial Tears Ointment Nationwide
Akorn is recalling all lots of Artificial Tears Ointment nationwide due to manufacturing compliance deviations. The company went out of business and was unable to complete required 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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0826-2023·2023-06-07
Lorazepam Oral Concentrate Recalled Due to Manufacturing Practice Deviations
Akorn, Inc. is recalling all lots of Lorazepam Oral Concentrate (2 mg/mL) due to Current Good Manufacturing Practice deviations. The manufacturer went out of business and could not complete required stability studies.
Product
Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0862-2023·2023-06-07
Pilocarpine Hydrochloride Ophthalmic Solution Recalled for Manufacturing Compliance Deviations
The FDA has recalled all lots of Pilocarpine Hydrochloride Ophthalmic Solution 4% due to manufacturing process deviations. The distributor ceased operations and cannot complete required stability testing.
Product
Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0795-2023·2023-06-07
Clobetasol Propionate Ointment recalled due to manufacturing compliance failures
Akorn, Inc. is recalling all lots of Clobetasol Propionate Ointment 0.05% due to manufacturing practice violations and inability to complete required stability studies. Product was distributed nationwide in the USA and Puerto Rico.
Product
Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0847-2023·2023-06-07
Sufenta Injection Recalled Due to Manufacturing Compliance Deviations
Akorn Inc. is recalling all lots of Sufenta (Sufentanil Citrate Injection) distributed nationwide. The manufacturer ceased operations and could not complete required stability studies to verify drug safety and effectiveness over time.
Product
Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, Rx only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0835-2023·2023-06-07
FDA Recalls Pilocarpine Ophthalmic Solution Due to Incomplete Stability Studies
Akorn Inc. recalled all lots of Pilocarpine Hydrochloride Ophthalmic Solution 1% nationwide due to CGMP deviations. The firm went out of business and could not complete required stability studies.
Product
Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide