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Recall totals

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

37,066
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,786
Class I recallsReasonable probability of serious health consequences
24,313
Class II recallsTemporary or medically reversible health consequences
2,876
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 2,072 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 announced by month (Year to date)

A chart of recalls grouped by month.

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Source: FDA and USDA public dataLast updated

Summary (Year to date)

  • 1,527 recalls have been announced year to date.
  • Aug 2026 was 24% lower than the previous complete period (Jul 2026: 240).
  • The highest complete period was Jun 2026 (297).
  • Sep 2026 is incomplete and not included in the figures above.
  • Complete data
  • Incomplete
Recalls by class

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

Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2

Showing 3,281–3,300 of 18,528 recalls

FDA Recall Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 Ongoing Historical 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 →

FDA Recall Ongoing Historical recordClass II

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

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 Ongoing Historical recordClass II

Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 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 Ongoing Historical recordClass II

Levocarnitine Oral Solution, USP, 118 mL bottles, 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.
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.