All Recalls

95,018 total recalls in our database

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 NDCs

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

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

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Other Drugs Nationwide View Details →

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 needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only, Manufactured by: GP Pharm S.A. Barcelona, Spain (ESP) -08777, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

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

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

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

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

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

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2

SSM Health Care St. Louis

💊 Drugs Class I - Dangerous

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

May 9, 2023 Prescription Drugs View Details →

Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

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

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.

Denison Pharmaceuticals

💊 Drugs Class I - Dangerous

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

May 3, 2023 Other Drugs Nationwide View Details →

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

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn

💊 Drugs Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →