DrugJun 7, 2023
Akorn Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles recall — FDA D-0835-2023
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class IIFDA: OngoingAkorn, Inc.
Latest records
Latest recalls — page 275
The newest recall records with useful source details are listed here.
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.
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.
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
August 2026149 records · 4 categoriesJuly 2026371 records · 4 categoriesJune 2026375 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categoriesOctober 2025455 records · 4 categoriesSeptember 2025285 records · 4 categories