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Recall totals

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

37,497
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,881
Class I recallsReasonable probability of serious health consequences
24,543
Class II recallsTemporary or medically reversible health consequences
2,935
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 2,098 recalls
Most affected stateHawaii 200 recalls mention this state

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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)

  • 1,956 recalls have been announced year to date.
  • Oct 2026 was 4% higher than the previous complete period (Sep 2026: 209).
  • The highest complete period was Jun 2026 (300).
  • Nov 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 II24,543
Class I9,881
Class III2,935
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,543
Class I9,881
Class III2,935
Not Yet Classified2

Showing 19,341–19,360 of 21,347 recalls

FDA Recall TerminatedTerminated: June 16, 2015Historical recordClass III

CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.

by ChiroNutraceutical LLC

Reason
Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.
Published
September 17, 2014
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: September 23, 2014Historical recordClass II

PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3666-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Published
September 10, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 23, 2014Historical recordClass II

PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3664-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Published
September 10, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 23, 2014Historical recordClass II

PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3663-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Published
September 10, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 23, 2014Historical recordClass II

PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3670-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Published
September 10, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 23, 2014Historical recordClass II

PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Published
September 10, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 23, 2014Historical recordClass II

Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Published
September 10, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 23, 2014Historical recordClass II

Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Published
September 10, 2014
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: September 23, 2014Historical recordClass II

PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Published
September 10, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: September 23, 2014Historical recordClass II

Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3

by Apotex Inc.

Reason
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Published
September 10, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: February 8, 2016Historical recordClass II

Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013

by Sage Products Inc

Reason
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Published
September 10, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: February 1, 2016Historical recordClass II

OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21

by Qualitest Pharmaceuticals

Reason
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Published
September 10, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: December 3, 2014Historical recordClass I

Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.

by Pharmakon Pharmaceuticals

Reason
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Published
September 3, 2014
Distribution
United States: TX, IL, MD, IN

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FDA Recall TerminatedTerminated: December 3, 2014Historical recordClass II

Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.

by Pharmakon Pharmaceuticals

Reason
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Published
September 3, 2014
Distribution
United States: TX, IL, MD, IN

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FDA Recall TerminatedTerminated: December 3, 2014Historical recordClass I

Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.

by Pharmakon Pharmaceuticals

Reason
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Published
September 3, 2014
Distribution
United States: TX, IL, MD, IN

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FDA Recall TerminatedTerminated: December 3, 2014Historical recordClass I

Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.

by Pharmakon Pharmaceuticals

Reason
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Published
September 3, 2014
Distribution
United States: TX, IL, MD, IN

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FDA Recall TerminatedTerminated: October 7, 2016Historical recordClass II

All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX

by Abrams Royal Pharamacy

Reason
Lack of Assurance of Sterility
Published
September 3, 2014
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 7, 2016Historical recordClass I

MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX

by Abrams Royal Pharamacy

Reason
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
Published
September 3, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: July 23, 2015Historical recordClass III

Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.

by Mylan Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Published
September 3, 2014
Distribution
Nationwide

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FDA Recall TerminatedTerminated: December 22, 2014Historical recordClass II

VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451.

by Alkermes, Inc.

Reason
Customer complaints for failure to deliver the dose.
Published
September 3, 2014
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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