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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

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/whole-foods-market-issues-allergy-alert-undeclared-egg-cabricharme-cheesePublished September 11, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 14, 2026 ET

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

Recalls by class
Class	Recalls
Class II	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

Recalls by class
Class	Recalls
Class II	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

FDA Recall Ongoing Historical recordClass II

HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2

by SSM Health Care St. Louis DBA SSM St. Clare Health Center

Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Published: June 7, 2023
Distribution: Product was distributed in Missouri.

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FDA Recall Ongoing Historical recordClass II

Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.

by Denison Pharmaceuticals, LLC

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

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FDA Recall Ongoing Historical 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

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FDA Recall Ongoing Historical 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

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FDA Recall Ongoing Historical 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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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 →

Data last updated: September 14, 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.