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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

Newest recallhttps://www.fsis.usda.gov/recalls-alerts/kayem-foods-inc--recalls-meat-and-poultry-products-due-possible-temperature-abusePublished October 17, 2026

Most affected stateHawaii 200 recalls mention this state

State: VI ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated October 19, 2026 ET

Summary (Year to date)

1,739 recalls have been announced year to date.
Sep 2026 was 15% higher than the previous complete period (Aug 2026: 182).
The highest complete period was Jun 2026 (300).
Oct 2026 is incomplete and not included in the figures above.

Complete data
Incomplete

Recalls by class

Recalls by class
Class	Recalls
Class II	24,397
Class I	9,852
Class III	2,897
Not Yet Classified	2

Recalls by class
Class	Recalls
Class II	24,397
Class I	9,852
Class III	2,897
Not Yet Classified	2

FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

View recall →

FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

View recall →

FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

View recall →

FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

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FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

View recall →

FDA Recall OngoingHistorical 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.
Published: June 7, 2023
Distribution: Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, 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: October 19, 2026 ET

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.