RecallWatchUSA

Home / Brands / Akorn

Akorn Recalls

192 recalls on record · October 1, 2014 to June 7, 2023 · Drugs

Recalls by year

14
15
16
17
18
19
20
21
22
23

Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

June 7, 2023DrugsFDA
Akorn, Inc. recalls Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, I
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akor
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn O
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Op
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Compa
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gur
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., G
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophiliz
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. A
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Compan
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use On
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmi
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. AL
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bo
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
February 15, 2023DrugsFDA
Akorn, Inc. recalls Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distrib
Hazard: Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
January 25, 2023DrugsFDA
Akorn, Inc. recalls Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 6004
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL droppe
Hazard: CGMP Deviations: