DrugJun 7, 2023
Akorn Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion recall — FDA D-0818-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
Recall history in this database
Classification mix: Class II: 77, Class III: 2.
DrugJun 7, 2023
Akorn Clobetasol Propionate Cream, USP, 0.05% recall — FDA D-0794-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles recall — FDA D-0864-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray recall — FDA D-0787-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles recall — FDA D-0792-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes recall — FDA D-0786-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes recall — FDA D-0821-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles recall — FDA D-0827-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Ferrous Sulfate Iron Supplement Drops recall — FDA D-0803-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only recall — FDA D-0785-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles recall — FDA D-0860-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes recall — FDA D-0795-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Rifampin Capsules USP, 300 mg recall — FDA D-0841-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous recall — FDA D-0802-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial recall — FDA D-0863-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye recall — FDA D-0779-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn AK-POLY-BAC recall — FDA D-0788-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials recall — FDA D-0825-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use recall — FDA D-0830-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles recall — FDA D-0797-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn IC-Green recall — FDA D-0812-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles recall — FDA D-0857-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles recall — FDA D-0861-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Levofloxacin Oral Solution, 25 mg/mL recall — FDA D-0819-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Akorn, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.