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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 6,081–6,100 of 17,327 recalls

FDA Recall United States Terminated Historical recordClass II

EMILIA FOODS SRL

Product
Good & Gather Four Cheese Gnocchi, Net Wt. 16 oz. (454g), Ke…
Reason
Good and Gather Four Cheese Gnocchi may contain foreign material.
Published
February 3, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This is a compounded (re-packaged) drug. Not for Resale, Hospital/Office use only. Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Published
January 27, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035

by Complete Pharmacy and Medical Solutions, LLC.

Reason
CGMP deviations: Lack of potency testing.
Published
January 27, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035

by Complete Pharmacy and Medical Solutions, LLC.

Reason
CGMP deviations: Lack of potency testing.
Published
January 27, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035

by Complete Pharmacy and Medical Solutions, LLC.

Reason
CGMP deviations: Lack of potency testing.
Published
January 27, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035

by Complete Pharmacy and Medical Solutions, LLC.

Reason
CGMP deviations: Lack of potency testing.
Published
January 27, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10.

by Allergan, PLC.

Reason
Labeling: Missing instructions for use insert
Published
January 27, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11

by American Health Packaging

Reason
Failed Dissolution Specifications
Published
January 27, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)

by Genus Lifesciences Inc.

Reason
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Published
January 20, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.

by Precision Dose Inc.

Reason
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Published
January 20, 2021
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01

by Nostrum Laboratories Inc

Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Published
January 20, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Published
January 20, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01

by KVK-Tech, Inc.

Reason
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Published
January 20, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032

by US Compounding Inc

Reason
Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
Published
January 20, 2021
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL

by Sunstar Americas, Inc.

Reason
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Published
January 20, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16

by Akorn, Inc.

Reason
Defective container: Customer complaints for oral solution leaking from bottles.
Published
January 20, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Published
January 13, 2021
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.