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Recall totals

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

37,211

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

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/frutas-y-hortalizas-del-sur-sa-expands-recalls-include-additional-lots-great-value-frozen-organicPublished October 2, 2026

Most affected stateHawaii 200 recalls mention this state

State: ND ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated October 4, 2026 ET

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

Recalls by class
Class	Recalls
Class II	24,366
Class I	9,841
Class III	2,892
Not Yet Classified	2

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Recalls by class
Class	Recalls
Class II	24,366
Class I	9,841
Class III	2,892
Not Yet Classified	2

FDA Recall Terminated Historical recordClass III

METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771

by VistaPharm, Inc.

Reason: Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"
Published: September 5, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American Health Packaging, 2550-A John Glenn Avenue, Columbus, OH 43217, barcode 6808432511; Carton labeling Dist by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977, NDC 68084-325-21.

by American Health Packaging

Reason: Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Published: September 5, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.

by Apotex Corp.

Reason: CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Published: September 5, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20

by GlaxoSmithKline Inc

Reason: Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Published: September 5, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17.

by Bracco Diagnostics Inc

Reason: Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Published: September 5, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541

by Capco Custom Packaging Inc

Reason: Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
Published: September 5, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15

by Bracco Diagnostics Inc

Reason: Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Published: September 5, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3

by Apotex Corp.

Reason: Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Published: September 5, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9

by Apotex Corp.

Reason: Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Published: September 5, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,

by Galderma Laboratories, L.P.

Reason: Subpotent; fluocinolone acetonide.
Published: September 5, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.

by Prometheus Laboratories Inc.

Reason: Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Published: August 29, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50

by VistaPharm, Inc.

Reason: Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume
Published: August 29, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561; b) 5-count blister pack UPC Code 0972859402; c) 10-count bottle UPC code 0913251017 bottles, Manufactured by The Menz Club, LLC, 103 W. Washington Street, Suite B5, Ridgeland, MS 39157, Phone: 601-866-6746

by The Menz Club, LLC

Reason: Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs.
Published: August 29, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags. Product is shipped in 80 lb bags, 350 lb drums & 2000 lb semi-bulk sacks. Manufactured by Morton Salt, Inc., Chicago, Illinois 60606-1743.

by Morton Salt Co.

Reason: Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride.
Published: August 29, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.

by Noven Pharmaceuticals, Inc.

Reason: Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Published: August 29, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5555-3.

by Noven Pharmaceuticals, Inc.

Reason: Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Published: August 29, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.

by Noven Pharmaceuticals, Inc.

Reason: Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Published: August 29, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04

by Hill Dermaceuticals, Inc.

Reason: Subpotent; fluocinolone acetonide
Published: August 22, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd., Ahmedabad, India; Dist By: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, Pkg by: American Health Packaging, Col. OH 43217, NDC 68084-343-21, blister barcode 6808434311

by American Health Packaging

Reason: Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".
Published: August 22, 2012
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

ZINC CHLORIDE 10MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason: Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Published: August 22, 2012
Distribution: Nationwide

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Data last updated: October 4, 2026 ET

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.