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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.

37,205
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 16,121–16,140 of 18,068 recalls

FDA Recall Terminated Historical recordClass II

Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us

by Medical Supply Liquidators Llc

Reason
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Published
August 13, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us

by Medical Supply Liquidators Llc

Reason
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Published
August 13, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us

by Medical Supply Liquidators Llc

Reason
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Published
August 13, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us

by Medical Supply Liquidators Llc

Reason
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Published
August 13, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2.

by Novartis Pharmaceuticals Corp.

Reason
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Published
August 13, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11

by Janssen Pharmaceuticals, Inc.

Reason
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Published
August 13, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.

by Wockhardt Usa Inc.

Reason
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Published
August 13, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.

by Alexion Pharmaceuticals, Inc.

Reason
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Published
August 13, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.

by Caraco Pharmaceutical Laboratories, Ltd.

Reason
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Published
August 13, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.

by Caraco Pharmaceutical Laboratories, Ltd.

Reason
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Published
August 13, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10

by Sandoz Incorporated

Reason
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Published
August 6, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Published
August 6, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Published
August 6, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Published
August 6, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Published
August 6, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Published
August 6, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Published
August 6, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Published
August 6, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30

by Daiichi Sankyo Pharma Development

Reason
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Published
August 6, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90

by Jubilant Cadista Pharmaceuticals Inc.

Reason
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Published
August 6, 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.