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Recall totals

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

37,205
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,841
Class I recallsReasonable probability of serious health consequences
24,366
Class II recallsTemporary or medically reversible health consequences
2,892
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 2,073 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)

  • 1,714 recalls have been announced year to date.
  • Sep 2026 was 3% higher than the previous complete period (Aug 2026: 182).
  • The highest complete period was Jun 2026 (297).
  • 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 II24,366
Class I9,841
Class III2,892
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,366
Class I9,841
Class III2,892
Not Yet Classified2

Showing 15,601–15,620 of 18,503 recalls

FDA Recall Terminated Historical recordClass II

Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Published
June 24, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25 Tablet Cartons, Distributed by Harmon Stores, Inc. 650 Liberty Ave. Union, NJ 07083, UPC: 3 62211 93292 2. c) Health A2Z Maximum Strength HEARTBURN RELIEF, 8 Tablet Cartons, Manufactured for: A&Z Pharmaceutical Inc. Hauppauge, NY 11788. UPC: 3 62211 34929 4. d) MARKET BASKET Maximum Strength HEARTBURN RELIEF ACID CONTROL, 30 Tablet Cartons, Distributed by: Demoulas Supermarkets, Inc. 875 East St. Tewksbury, MA 01876, UPC: 0 49705 83147 2.

by Allegiant Health

Reason
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Published
June 24, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03

by Baxter Healthcare Corp

Reason
Subpotent Drug; out of specification results for heparin raw material
Published
June 17, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications
Published
June 17, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications
Published
June 17, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Published
June 17, 2015
Distribution
MT and ND

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FDA Recall Terminated Historical recordClass II

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Published
June 17, 2015
Distribution
MT and ND

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FDA Recall Terminated Historical recordClass II

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Published
June 17, 2015
Distribution
MT and ND

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FDA Recall Terminated Historical recordClass II

Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Published
June 17, 2015
Distribution
MT and ND

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FDA Recall Terminated Historical recordClass II

Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Published
June 17, 2015
Distribution
MT and ND

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FDA Recall Terminated Historical recordClass II

Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Published
June 17, 2015
Distribution
MT and ND

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FDA Recall Terminated Historical recordClass II

Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Published
June 17, 2015
Distribution
MT and ND

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FDA Recall Terminated Historical recordClass II

Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Published
June 17, 2015
Distribution
MT and ND

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FDA Recall Terminated Historical recordClass II

Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Published
June 17, 2015
Distribution
MT and ND

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FDA Recall Terminated Historical recordClass II

Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Published
June 17, 2015
Distribution
MT and ND

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FDA Recall Terminated Historical recordClass II

Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Published
June 17, 2015
Distribution
MT and ND

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FDA Recall Terminated Historical recordClass II

Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

by Montana Compounding Pharmacy

Reason
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Published
June 17, 2015
Distribution
MT and ND

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FDA Recall Terminated Historical recordClass II

Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.

by Valeant Pharmaceuticals North America LLC

Reason
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Published
June 17, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06

by Sandoz, Inc

Reason
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Published
June 10, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.

by Fresenius Kabi USA, LLC

Reason
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Published
June 10, 2015
Distribution
Nationwide

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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.