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.
Monthly breakdown
2023 recalls by month
Select a month to review the recall records reported during that period.
December 2023295 records · 4 categoriesNovember 2023387 records · 4 categoriesOctober 2023214 records · 4 categoriesSeptember 2023253 records · 4 categoriesAugust 2023478 records · 4 categoriesJuly 2023263 records · 4 categoriesJune 2023339 records · 4 categoriesMay 2023410 records · 4 categoriesApril 2023189 records · 4 categoriesMarch 2023788 records · 4 categoriesFebruary 2023253 records · 4 categoriesJanuary 2023205 records · 4 categories
2023 recalls — page 92
Records are ordered by the best available source date.
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.
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 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 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 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 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
G-Supress DX recall — FDA D-0868-2023
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Class IFDA: TerminatedNovis PR, LLC dba Kramer Novis
About the 2023 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.