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Recall totals

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

37,113
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,793
Class I recallsReasonable probability of serious health consequences
24,343
Class II recallsTemporary or medically reversible health consequences
2,887
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
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)

  • 1,527 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

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

Recalls by class
ClassRecalls
Class II24,343
Class I9,793
Class III2,887
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,343
Class I9,793
Class III2,887
Not Yet Classified1

Showing 5,981–6,000 of 18,020 recalls

FDA Recall Terminated Historical recordClass II

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Published
September 8, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Published
September 8, 2021
Distribution
Nationwide

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FDA Recall United States Terminated Historical recordClass II

Rocky Top Farm

Product
Rocky Top Farms Cherry Butter sold in 1 gallon food service…
Reason
Undeclared milk
Published
September 8, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80

by Eli Lilly & Company

Reason
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.

by KVK-Tech, Inc.

Reason
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01

by Hikma Pharmaceuticals USA Inc.

Reason
Labeling: Not elsewhere classified: Mislabeling
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030

by HIS ENTERPRISE INC

Reason
Marketed without ANDA/NDA approval
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59

by Teligent Pharma, Inc.

Reason
Defective container: possibility for lack of seal integrity.
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01

by SterRx, LLC

Reason
Non-Sterility: firm's third party lab confirmed microbial contamination.
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4

by SigmaPharm Laboratories LLC

Reason
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01

by Custopharm, Inc.

Reason
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178.

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1,

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Published
September 1, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01

by XELLIA PHARMACEUTICALS USA, LLC

Reason
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Published
September 1, 2021
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.