Recalls by year
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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 Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 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 Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 600
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 6
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured b
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, 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 Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, L
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 6004
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating C
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, R
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., 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 Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc.,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bott
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Fo
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL v
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufac
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmac
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufa
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.