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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 2,581–2,600 of 18,047 drug recalls

Drug Recall Ongoing Historical recordClass II

Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, Rx only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recall initiated
April 26, 2023
Reported by FDA
June 7, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.

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