Akorn, Inc. Recalls — U.S. Recall Records

Recall history in this database

Classification mix: Class II: 77, Class III: 2.

DrugJun 7, 2023

Akorn Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules recall — FDA D-0799-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Prednisolone Oral Solution, USP, 15 mg/5 mL recall — FDA D-0836-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles recall — FDA D-0854-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules recall — FDA D-0850-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free recall — FDA D-0808-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Apraclonidine Ophthalmic Solution 0.5% recall — FDA D-0784-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL recall — FDA D-0780-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes recall — FDA D-0824-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles recall — FDA D-0845-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray recall — FDA D-0791-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or recall — FDA D-0809-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg) recall — FDA D-0807-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles recall — FDA D-0810-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL recall — FDA D-0848-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles recall — FDA D-0826-2023

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, 0.1%, 5 mL bottles recall — FDA D-0833-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Lactulose Solution, USP recall — FDA D-0815-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles recall — FDA D-0793-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) recall — FDA D-0811-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL recall — FDA D-0856-2023

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 4%, 15 mL bottles recall — FDA D-0862-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle recall — FDA D-0855-2023

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, 150 mg, 30-count bottles recall — FDA D-0840-2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL recall — FDA D-0837-2023

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.