FDA Drug Recalls

316 recalls, newest first

Class II · Moderate risk Ongoing Apr 26, 2023

Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL…

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

Akorn, Inc. D-0849-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by…

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

Akorn, Inc. D-0848-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For…

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

Akorn, Inc. D-0847-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee…

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

Akorn, Inc. D-0846-2023

Class II · Moderate risk Ongoing Apr 26, 2023

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

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

Akorn, Inc. D-0845-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

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

Akorn, Inc. D-0844-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

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

Akorn, Inc. D-0843-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn…

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

Akorn, Inc. D-0842-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating…

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

Akorn, Inc. D-0841-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031…

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

Akorn, Inc. D-0840-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL…

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

Akorn, Inc. D-0839-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee…

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

Akorn, Inc. D-0838-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company…

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

Akorn, Inc. D-0837-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn…

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

Akorn, Inc. D-0836-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company…

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

Akorn, Inc. D-0835-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL…

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

Akorn, Inc. D-0834-2023

Class II · Moderate risk Ongoing Apr 26, 2023

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

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

Akorn, Inc. D-0833-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031…

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

Akorn, Inc. D-0832-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Inc…

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

Akorn, Inc. D-0831-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by…

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

Akorn, Inc. D-0830-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045…

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

Akorn, Inc. D-0829-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn…

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

Akorn, Inc. D-0828-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee…

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

Akorn, Inc. D-0827-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC…

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

Akorn, Inc. D-0826-2023

Class II · Moderate risk Ongoing Apr 26, 2023

Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL…

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

Akorn, Inc. D-0825-2023