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Research historical outbreak investigations and the full recall archive, with charts, trends, and advanced filters. Looking for what's happening right now instead? See current Health Alerts.

Recall totals

All FDA and USDA recalls in Public Health Trace, June 2012 to October 2026.

37,271
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,852
Class I recallsReasonable probability of serious health consequences
24,397
Class II recallsTemporary or medically reversible health consequences
2,897
Class III recallsNot likely to cause adverse health consequences

Quick insights

A snapshot of the most notable patterns across all recorded FDA and USDA recalls.

Most recalled product100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap. 53 recalls
Most common hazardLack of Assurance of Sterility 2,085 recalls
Most affected stateHawaii 200 recalls mention this state

Download matching recalls as CSV

CSV exports include up to 5,000 matching rows (applying your current filters), not the full dataset if it's larger.

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Recalls by class

A bar chart of the total number of recalls in this dataset by recall class.

Recalls by class
ClassRecalls
Class II24,397
Class I9,852
Class III2,897
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,397
Class I9,852
Class III2,897
Not Yet Classified2

Showing 3,041–3,060 of 17,287 recalls

FDA Recall OngoingHistorical recordClass II

Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.

by Denison Pharmaceuticals, LLC

Reason
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Tropicamide Ophthalmic Solution, USP 0.1%, 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Valproic Acid Oral Solution, USP, 250mg/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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Tobramycin Ophthalmic Solution, USP 0.3%, 5mL 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

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

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

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

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Lidocaine HCl Jelly USP, 2%, 5mL 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass 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

by Akorn, Inc.

Reason
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Published
June 7, 2023
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Levofloxacin Ophthalmic Solution, 0.5%, 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.
Published
June 7, 2023
Distribution
Nationwide

View recall →

Data last updated:

Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions. Read the full medical disclaimer.

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