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Recall totals

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

37,449
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,872
Class I recallsReasonable probability of serious health consequences
24,509
Class II recallsTemporary or medically reversible health consequences
2,932
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 2,096 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 II24,509
Class I9,872
Class III2,932
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,509
Class I9,872
Class III2,932
Not Yet Classified2

Showing 11,681–11,700 of 21,307 recalls

FDA Recall OngoingHistorical recordClass II

LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda

by Torrent Pharma Inc.

Reason
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Published
February 27, 2019
Distribution
Nationwide

View recall →

FDA Recall OngoingHistorical recordClass II

LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda

by Torrent Pharma Inc.

Reason
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Published
February 27, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: October 30, 2019Historical recordClass III

Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.

by Advanced Pharma Inc.

Reason
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Published
February 27, 2019
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 30, 2019Historical recordClass III

Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99.

by Advanced Pharma Inc.

Reason
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Published
February 27, 2019
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 30, 2019Historical recordClass III

Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.

by Advanced Pharma Inc.

Reason
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Published
February 27, 2019
Distribution
Nationwide

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FDA Recall United States TerminatedTerminated: May 17, 2019Historical recordClass II

Ardent Mills, LLC

Product
MEMBERS MARK SELF RISE FLR 25LB
Reason
Ardent Mills is voluntarily recalling certain lots of Self-Rising Flour because it has the potential to be contaminated with Salmonella.
Published
February 27, 2019
Distribution
Nationwide

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FDA Recall United States TerminatedTerminated: May 17, 2019Historical recordClass II

Ardent Mills, LLC

Product
WESTCREEK H&R SELF RISE AP FLR 25LB and 50LB
Reason
Ardent Mills is voluntarily recalling certain lots of Self-Rising Flour because it has the potential to be contaminated with Salmonella.
Published
February 27, 2019
Distribution
Nationwide

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FDA Recall United States TerminatedTerminated: May 17, 2019Historical recordClass II

Ardent Mills, LLC

Product
HILLTOP HEARTH SELF RISE FLR 25LB and 50LB
Reason
Ardent Mills is voluntarily recalling certain lots of Self-Rising Flour because it has the potential to be contaminated with Salmonella.
Published
February 27, 2019
Distribution
Nationwide

View recall →

FDA Recall United States TerminatedTerminated: May 17, 2019Historical recordClass II

Ardent Mills, LLC

Product
ARDENT H&R SR FLR, 25LB, 50 LB, and 25LB (PC)-309951, packag…
Reason
Ardent Mills is voluntarily recalling certain lots of Self-Rising Flour because it has the potential to be contaminated with Salmonella.
Published
February 27, 2019
Distribution
Nationwide

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FDA Recall TerminatedTerminated: April 4, 2023Historical recordClass I

Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 UPC 343598637525 ---- NDC 43598-637-52

by Dr. Reddy's Laboratories, Inc.

Reason
Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
Published
February 20, 2019
Distribution
Nationwide

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FDA Recall TerminatedTerminated: March 30, 2021Historical recordClass II

Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Published
February 20, 2019
Distribution
Nationwide

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FDA Recall TerminatedTerminated: March 30, 2021Historical recordClass II

Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Published
February 20, 2019
Distribution
Nationwide

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FDA Recall TerminatedTerminated: January 26, 2021Historical recordClass III

Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.

by Dr. Reddy's Laboratories, Inc.

Reason
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Published
February 20, 2019
Distribution
Nationwide

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FDA Recall TerminatedTerminated: March 29, 2023Historical recordClass II

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4.

by Tris Pharma Inc.

Reason
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Published
February 20, 2019
Distribution
Nationwide

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FDA Recall TerminatedTerminated: March 29, 2023Historical recordClass II

infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.

by Tris Pharma Inc.

Reason
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: March 29, 2023Historical recordClass II

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23.

by Tris Pharma Inc.

Reason
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: July 8, 2020Historical recordClass III

Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-521-01.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Published
February 20, 2019
Distribution
Nationwide

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FDA Recall TerminatedTerminated: July 8, 2020Historical recordClass III

Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); and b) 90-count bottles (NDC 0187-0798-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: July 8, 2020Historical recordClass III

Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottles (NDC 0187-0797-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Published
February 20, 2019
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: July 8, 2020Historical recordClass III

Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Published
February 20, 2019
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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