Product Recalls in 2023
4,662 recalls issued this year
324
CPSC
2,220
FDA Food
1,122
FDA Drug
996
NHTSA
FDA Drug
Class II
Ongoing
AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
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
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
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
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
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
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
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
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class I
Ongoing
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
April 26, 2023
Gadget Island, Inc
140 blister packs units
FDA Drug
Class II
Ongoing
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class I
Ongoing
Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.
April 26, 2023
Gadget Island, Inc
628 blister cards units
FDA Drug
Class II
Ongoing
Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge need
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
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
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
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 do
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
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. AL
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class I
Ongoing
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
April 26, 2023
Gadget Island, Inc
18 blister cards units
FDA Drug
Class II
Ongoing
Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- Lake Forest, IL 60045. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
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
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
April 26, 2023
Akorn, Inc.
N/A units
FDA Drug
Class II
Ongoing
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
April 26, 2023
Akorn, Inc.
N/A units