The Recall Desk

Manufacturer

Akorn, Inc.

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

What the numbers show

Total
192
Critical
0
Severe
10
Most recent
2023-06-07

Of the 192 recalls from Akorn, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (5%) are Severe.

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.

76–100 of 192

  • ModerateFDA (Drugs)·D-0829-2023·2023-06-07

    Moxifloxacin HCl Ophthalmic Solution Recalled Due to CGMP Compliance Deviation

    Moxifloxacin HCl Ophthalmic Solution 0.5% is being recalled because manufacturer Akorn, Inc. ceased operations and cannot complete required stability studies. All lots distributed nationwide in the USA and Puerto Rico are affected.

    Product
    Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2023·2023-06-07

    Ropivacaine Hydrochloride Injection Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Ropivacaine Hydrochloride Injection USP 0.5% nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required FDA testing.

    Product
    Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0864-2023·2023-06-07

    Tropicamide Ophthalmic Solution Recalled by Akorn for CGMP Deviations

    Akorn Operating Company is recalling all lots of Tropicamide Ophthalmic Solution 0.1% nationwide due to Good Manufacturing Practice (CGMP) deviations. The firm ceased operations and could not complete required 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0781-2023·2023-06-07

    Acetic Acid Otic Solution recalled due to manufacturing deviations and unverified stability

    Akorn is recalling all lots of Acetic Acid Otic Solution nationwide due to manufacturing practice deviations. The firm went out of business and could not complete stability studies required to verify the product remained safe and effective.

    Product
    Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0855-2023·2023-06-07

    Vitamin D Supplement Drops Recalled Due to Manufacturing Practice Violations

    Akorn, Inc. is recalling Vitamin D Supplement Drops (400 IU, Cherry Flavored, 50mL) distributed nationwide because the firm ceased operations and could not complete required stability studies.

    Product
    Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0787-2023·2023-06-07

    Azelastine Hydrochloride Nasal Spray Recalled Due to Manufacturing Deviations

    Akorn, Inc. is recalling all lots of Azelastine Hydrochloride Nasal Spray nationwide due to manufacturing process deviations. The firm ceased operations and could no longer conduct required 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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0856-2023·2023-06-07

    XOPENEX Inhalation Solution Recalled Due to Manufacturing Compliance Issues

    Akorn, Inc. is recalling all lots of XOPENEX (levalbuterol HCl) inhalation solution because the company went out of business and cannot continue required stability studies. The firm's manufacturing deviations affect product safety verification.

    Product
    XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0793-2023·2023-06-07

    Cimetidine HCl Oral Solution Recalled Due to Manufacturing Compliance Deviations

    Akorn, Inc. is recalling all lots of Cimetidine HCl Oral Solution 300mg/5mL nationwide due to CGMP deviations. The firm ceased operations and could not complete required stability studies.

    Product
    Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0788-2023·2023-06-07

    AK-POLY-BAC Ophthalmic Ointment Recall for Manufacturing Compliance Deviations

    Akorn, Inc. recalls all lots of AK-POLY-BAC ophthalmic ointment nationwide because the company ceased operations and could not complete required stability testing.

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0848-2023·2023-06-07

    Akorn Antibiotic Suspension Recalled Due to CGMP Deviations and Unverified Stability

    Akorn recalls all lots of Sulfamethoxazole & Trimethoprim Oral Suspension (200mg/40mg per 5mL) nationwide due to inability to complete required stability studies after the company ceased operations.

    Product
    Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0813-2023·2023-06-07

    Akorn Ketorolac Eye Drops Recalled Due to Manufacturing Quality Deviations

    Akorn, Inc. is recalling all lots of Ketorolac Tromethamine Ophthalmic Solution 0.5% because the manufacturer went out of business and cannot complete required stability testing.

    Product
    Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0265-2023·2023-02-15

    Akorn Atropine Sulfate Eye Solution Recalled for Failed Stability Testing

    Akorn is recalling 45,117 bottles of Atropine Sulfate Ophthalmic Solution because stability testing found viscosity measurements out of specification. The affected product should not be used.

    Product
    Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0139-2023·2023-01-25

    FDA Recalls Nationwide Supply of Erythromycin Ophthalmic Ointment for Manufacturing Deviations

    Akorn, Inc. is recalling 36,455 cartons of Erythromycin Ophthalmic Ointment USP 0.5% nationwide due to manufacturing process deviations. The company voluntarily initiated this Class II recall.

    Product
    Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0153-2023·2023-01-25

    Proparacaine Ophthalmic Solution Recalled for Manufacturing Quality Deviations

    Akorn is voluntarily recalling Proparacaine Ophthalmic Solution nationwide due to Current Good Manufacturing Practice deviations.

    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0135-2023·2023-01-25

    Betaxolol ophthalmic solution recalled for manufacturing process violations

    Akorn, Inc. is voluntarily recalling Betaxolol ophthalmic solution (6,273 bottles, lot 1A08A, exp. 12/31/2022) due to manufacturing deviations. Consumers should consult their healthcare provider.

    Product
    Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0147-2023·2023-01-25

    Eye drop medication Olopatadine HCl recalled nationwide for manufacturing deviations

    Akorn, Inc. is recalling 31,073 bottles of Olopatadine HCl ophthalmic solution nationwide due to current good manufacturing practice deviations. This voluntary recall was initiated by the manufacturer.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0156-2023·2023-01-25

    Eye-drop drug recall: Timolol solution due to manufacturing deviations

    Akorn is recalling over 1.3 million bottles of Timolol Maleate eye drops distributed nationwide due to manufacturing process violations. The voluntary recall addresses risks from Current Good Manufacturing Practice deviations.

    Product
    Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0141-2023·2023-01-25

    Ketorolac Tromethamine ophthalmic solution recalled due to manufacturing deviations

    Akorn is recalling Ketorolac Tromethamine Ophthalmic Solution nationwide due to manufacturing practice deviations. The voluntary recall affects multiple lot numbers of the 0.5% formulation.

    Product
    Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0133-2023·2023-01-25

    Drug Recall: Artificial Tears Eye Ointment Due to Manufacturing Deviations

    Akorn, Inc. is recalling Artificial Tears Ointment (1.16 million tubes nationwide) due to manufacturing practice deviations. The firm voluntarily initiated this recall.

    Product
    Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0132-2023·2023-01-25

    FDA Recalls Akorn AK-POLY-BAC Eye Ointment for CGMP Violations

    Akorn Inc. voluntarily recalls 36,025 tubes of AK-POLY-BAC Bacitracin/Polymixin B eye ointment nationwide due to manufacturing process deviations affecting product quality and sterility.

    Product
    AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0157-2023·2023-01-25

    Prescription Eye Drops Recalled for Manufacturing Control Deviations

    Akorn, Inc. is voluntarily recalling over 2 million bottles of Tobramycin Ophthalmic Solution due to Current Good Manufacturing Practice deviations affecting four product lots distributed nationwide.

    Product
    Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0150-2023·2023-01-25

    Antihistamine eye drops recalled due to manufacturing process deviations

    Akorn, Inc. is recalling 163,996 bottles of Olopatadine HCl Ophthalmic Solution 0.1% due to manufacturing process deviations. Affected lot numbers expire from October through December 2023.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0142-2023·2023-01-25

    Akorn recalls Levofloxacin eye drops due to manufacturing compliance issues

    Akorn, Inc. is recalling Levofloxacin Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 3,108 bottles distributed nationwide.

    Product
    Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0140-2023·2023-01-25

    FDA recalls GONAK ophthalmic drug solution for manufacturing deviations

    Akorn voluntarily recalled 196,254 bottles of GONAK ophthalmic solution nationwide due to CGMP manufacturing practice deviations. This professional-use eye solution is employed in gonioscopic examinations.

    Product
    GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0138-2023·2023-01-25

    Drug Recall: Erythromycin Ophthalmic Ointment Due to Manufacturing Deviations

    Akorn, Inc. recalls 1.1 million tubes of Erythromycin Ophthalmic Ointment nationwide due to manufacturing deviations. The voluntary, Class II recall was initiated by the firm.

    Product
    ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Akorn

American generic pharmaceuticals manufacturer

Country
United States

Official website

Source: Wikidata (Q20539236), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.