Drug and pharmaceutical recalls

17623 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2023-06-07FDA-DrugAkorn, Inc.Class II
Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.

← prevpage 74/588next →

Get notified about new drug recalls

Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.

Get the Sunday Brief