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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.

37,339
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,860
Class I recallsReasonable probability of serious health consequences
24,450
Class II recallsTemporary or medically reversible health consequences
2,901
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 2,095 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)

  • 1,739 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

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

Recalls by class
ClassRecalls
Class II24,450
Class I9,860
Class III2,901
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,450
Class I9,860
Class III2,901
Not Yet Classified2

Showing 7,021–7,040 of 17,454 recalls

FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

BUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe Assurance Infusion (713)533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: June 9, 2021Historical recordClass II

Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.

by Hikma Pharmaceuticals USA Inc.

Reason
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Published
January 22, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 27, 2021Historical recordClass II

TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800

by Assurance Infusion

Reason
Lack of sterility assurance.
Published
January 22, 2020
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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