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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 16,021–16,040 of 18,068 recalls

FDA Recall Terminated Historical recordClass II

CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC

by Qualitest Pharmaceuticals

Reason
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
Published
October 29, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07

by Forest Pharmaceuticals Inc

Reason
Failed Dissolution Specification; at the 6-month stability time point
Published
October 29, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC, Distributed by: Rugby Laboratories Livonia, MI 48150, NDC 0536-3606-96 Major Children's Mapap Suspension Liquid, Cherry Flavor, 4 FL OZ bottle, OTC, Distributed by: Major Pharmaceuticals Livonia, MI 48150 , NDC 0904-6308-20,

by Bio-pharm, Inc.

Reason
Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint.
Published
October 29, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195

by Sagent Pharmaceuticals Inc

Reason
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
Published
October 22, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15

by Valeant Pharmaceuticals International

Reason
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Published
October 22, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15

by Valeant Pharmaceuticals International

Reason
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Published
October 22, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002

by Gyma Laboratories Of Amer,Inc

Reason
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Published
October 22, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01

by Gyma Laboratories Of Amer,Inc

Reason
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Published
October 22, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004

by Gyma Laboratories Of Amer,Inc

Reason
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Published
October 22, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084

by Gyma Laboratories Of Amer,Inc

Reason
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Published
October 22, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05

by Hospira Inc.

Reason
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Published
October 22, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187-0141-90 10 mg 30 ct - NDC 0187-0142-30 10 mg 90 ct - NDC 0187-0142-90 10 mg 1000 ct - NDC 0187-0142-10 20 mg 30 ct - NDC 0187-0143-30 20 mg 90 ct - NDC 0187-0143-90 20 mg 1000 ct - NDC 0187-0143-10 NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles

by Valeant Pharmaceuticals North America LLC

Reason
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Published
October 22, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada

by Valeant Pharmaceuticals North America LLC

Reason
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Published
October 22, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.

by Avella of Deer Valley, Inc.

Reason
Crystallization: Formation of crystals observed in product.
Published
October 22, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.

by Zydus Pharmaceuticals USA Inc

Reason
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Published
October 22, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409 NDC 10361-793-01

by Bracco Diagnostic Inc

Reason
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Published
October 15, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1

by Gilead Sciences, Inc.

Reason
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Published
October 15, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

All sterile products within expiry

by Unique Pharmaceutical, Ltd

Reason
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
Published
October 15, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133

by Unique Pharmaceutical, Ltd

Reason
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
Published
October 15, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.

by VistaPharm, Inc.

Reason
Defective Container: Product leaks when inverted.
Published
October 15, 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.