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Recall totals

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

37,060

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,786

Class I recallsReasonable probability of serious health consequences

24,313

Class II recallsTemporary or medically reversible health consequences

2,876

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

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/freshpoint-issues-recall-due-improperly-declared-allergen-egg-chicken-salad-wedge-sandwichesPublished September 8, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 9, 2026 ET

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

Recalls by class
Class	Recalls
Class II	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

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Recalls by class
Class	Recalls
Class II	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

FDA Recall Ongoing Historical recordClass II

Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.

by MEDLINE INDUSTRIES, LP - Northfield

Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Published: September 3, 2025
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37

by Lannett Company Inc.

Reason: Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Published: September 3, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

by Amerisource Health Services LLC

Reason: CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Published: September 3, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.

by Baxter Healthcare Corporation

Reason: Discoloration
Published: September 3, 2025
Distribution: Nationwide

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FDA Recall United States Ongoing Historical recordClass II

The J.M. Smucker Company

Product: Hostess Ding Dongs CHOCOLATE CAKE WITH CREAMY FILLING 2.55 o…
Reason: Mold. The firm noticed an increase in customer complaints. They conducted a root cause investigation and discovered that one of their coolers had malfunctioning.
Published: September 3, 2025
Distribution: Product was shipped to the following sta…

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FDA Recall Ongoing Historical recordClass II

Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04

by VIONA PHARMACEUTICALS INC

Reason: Discoloration
Published: August 27, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Published: August 27, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.

by Cipla USA, Inc.

Reason: Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Published: August 27, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2

by Haleon US Holdings LLC

Reason: Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Published: August 27, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.

by PFIZER INC

Reason: Lack of Assurance of Sterility.
Published: August 27, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II