DrugJun 7, 2023
Akorn Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle recall — FDA D-0783-2023
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 91
Records are ordered by the best available source date.
DrugJun 7, 2023
Akorn DOCU LIQUID recall — FDA D-0801-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Acetic Acid Otic Solution, 15 mL per bottle recall — FDA D-0781-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes recall — FDA D-0831-2023
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 0.5%, 15 mL bottles recall — FDA D-0853-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton recall — FDA D-0777-2023
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Class IIFDA: TerminatedFresenius Medical Care Holdings, Inc.
DrugJun 7, 2023
Akorn Sufenta recall — FDA D-0847-2023
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 (Oral), 10g/15 mL recall — FDA D-0814-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles recall — FDA D-0796-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile recall — FDA D-0813-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles recall — FDA D-0852-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles recall — FDA D-0838-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles recall — FDA D-0839-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn DetomiSed (detomidine hydrochloride) recall — FDA D-0798-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
DrugJun 7, 2023
Akorn Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles recall — FDA D-0829-2023
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, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL recall — FDA D-0842-2023
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.
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 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 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 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 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 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
SSM Health Care St. Louis DBA SSM St. Clare HYDROmorphone HCl 10 mg in 0.9% Sodium recall — FDA D-0776-2023
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or…
Class IIFDA: OngoingSSM Health Care St. Louis DBA SSM St. Clare Health…
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.