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Recall totals

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

37,142
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,799
Class I recallsReasonable probability of serious health consequences
24,349
Class II recallsTemporary or medically reversible health consequences
2,891
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 II24,349
Class I9,799
Class III2,891
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,349
Class I9,799
Class III2,891
Not Yet Classified1

Showing 15,041–15,060 of 17,335 recalls

FDA Recall Terminated Historical recordClass III

PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Phenylephrine Hydrochloride 5 mg, alcohol 7%, (a) 4 fl oz bottle (NDC 0603-1588-54) and (b) 16 fl oz bottle (NDC 0603-1588-58) Rx only, Manufactured for QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811.

by Qualitest Pharmaceuticals

Reason
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Published
April 15, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose)

by American Health Packaging

Reason
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Published
April 8, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31

by Baxter Healthcare Corp

Reason
Lack of Assurance of Sterility; increased complaints received for leaks
Published
April 8, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04

by Baxter Healthcare Corp

Reason
Lack of Assurance of Sterility; increased complaints received for leaks
Published
April 8, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04

by Baxter Healthcare Corp.

Reason
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Published
April 1, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03

by Baxter Healthcare Corp.

Reason
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Published
April 1, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040.

by Bethel Nutritional Consulting, Inc

Reason
Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss
Published
April 1, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

by Mylan Institutional LLC

Reason
Lack of Assurance of Sterility; due to leaking vials
Published
April 1, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

by Mylan Institutional LLC

Reason
Lack of Assurance of Sterility; due to leaking vials
Published
April 1, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.

by West-Ward Pharmaceutical Corporation

Reason
Failed Impurities/Degradation Specifications; 12 month stability testing.
Published
April 1, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0073-02, UPC 3 11917 15114 4.

by Tarmac Products, Inc.

Reason
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
Published
March 25, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Published
March 25, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31

by Heritage Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Published
March 25, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31

by Heritage Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Published
March 25, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01

by Mutual Pharmaceutical Company, Inc.

Reason
Failed Impurities/Degradation Specifications: during long-term stability testing.
Published
March 25, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10

by Mylan Institutional LLC

Reason
Subpotent Drug and Failed Impurities/Degradation Specifications
Published
March 25, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow, KY, 42141, NDC 53150-317-01.

by Mylan Institutional LLC

Reason
Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL
Published
March 25, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58.

by Qualitest Pharmaceuticals

Reason
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Published
March 18, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.

by Micro Labs Usa, Inc S

Reason
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Published
March 18, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.

by Micro Labs Usa, Inc S

Reason
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Published
March 18, 2015
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.