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Recall totals

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

37,063

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/evergreen-fresh-sprouts-llc-recalls-broccoli-sprouts-because-possible-health-riskPublished September 10, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 11, 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 Terminated Historical recordClass II

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

by Hikma Injectables USA Inc

Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25

by Hikma Injectables USA Inc

Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack

by VIONA PHARMACEUTICALS INC

Reason: Crystallization
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack

by VIONA PHARMACEUTICALS INC

Reason: Crystallization
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles

by GNMart LLC

Reason: Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01

by SOMERSET THERAPEUTICS LLC

Reason: Failed Impurities/Degradation Specifications
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.

by AvKARE

Reason: Failed Dissolution Specifications
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03

by Lupin Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Published: January 8, 2025
Distribution: One US distributor in Ohio.

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FDA Recall United States Terminated Historical recordClass I

GARDNER'S CANDIES , INC

Product: Gardner's Candies Cappuccino Meltaway Bar 1.25 oz. (35g), It…
Reason: Product contains Undeclared Allergen Tree Nuts (Cashews)
Published: January 8, 2025
Distribution: The recalled product was distributed to…

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FDA Recall United States Terminated Historical recordClass II

Sam'S Club

Product: Member's Mark Hatch Chile Chicken Enchiladas, ready to cook,…
Reason: Presence of Listeria monocytogenes
Published: January 8, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

Reser's Fine Foods, Inc.

Product: FCF Item 404885, Gyro Kit No Trays. Each box consists of 2/5…
Reason: Salmonella. Item 404885, Gyro Kit No Trays contains implicated cucumber in the tzatziki sauce cup.
Published: January 8, 2025
Distribution: Distributed in AZ, CA, CO, FL, GA, IL, I…

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FDA Recall United States Terminated Historical recordClass I

Reser's Fine Foods, Inc.

Product: FCF Item 404884, Gyro Kit With Trays. Each tray consists of…
Reason: Salmonella. Item 404884, Gyro Kit With Trays contains implicated cucumber in the tzatziki sauce 2oz. cup.
Published: January 8, 2025
Distribution: Distributed in AZ, CA, CO, FL, GA, IL, I…

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FDA Recall United States Terminated Historical recordClass I

Reser's Fine Foods, Inc.

Product: Beef & Lamb Gyro Sandwich Express Meal Kit. Net wt. 31.8oz.…
Reason: Salmonella. Beef & Lamb Gyro Sandwich Express Meal Kit contains implicated cucumber in the tzatziki sauce 3oz. cup.
Published: January 8, 2025
Distribution: Distributed in AZ, CA, CO, FL, GA, IL, I…

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FDA Recall United States Terminated Historical recordClass I

Grimmway Enterprises, Inc. dba Grimmway Farms

Product: --- Organic Whole Carrots --- Organic Clip Carrots 50 Lbs C…
Reason: Potential contamination with E. coli O121:H19
Published: January 8, 2025
Distribution: Distribution Centers located in U.S. Sta…

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FDA Recall United States Terminated Historical recordClass I

Grimmway Enterprises, Inc. dba Grimmway Farms

Product: --- Organic Whole Carrots --- Organic Carrot 125/6 Cal-Orga…
Reason: Potential contamination with E. coli O121:H19
Published: January 8, 2025
Distribution: Distribution Centers located in U.S. Sta…

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FDA Recall United States Terminated Historical recordClass I

Grimmway Enterprises, Inc. dba Grimmway Farms

Product: --- Organic Baby Carrots --- Organic Baby Carrots 25 Grimmwa…
Reason: Potential contamination with E. coli O121:H19
Published: January 8, 2025
Distribution: Distribution Centers located in U.S. Sta…

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FDA Recall United States Terminated Historical recordClass I

Grimmway Enterprises, Inc. dba Grimmway Farms

Product: --- Organic Baby Carrots --- Orangic Baby Peeled Carrots 13/…
Reason: Potential contamination with E. coli O121:H19
Published: January 8, 2025
Distribution: Distribution Centers located in U.S. Sta…

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FDA Recall United States Terminated Historical recordClass I

Grimmway Enterprises, Inc. dba Grimmway Farms

Product: --- Organic Baby Carrots --- Organic Baby Peeled Carrots 12/…
Reason: Potential contamination with E. coli O121:H19
Published: January 8, 2025
Distribution: Distribution Centers located in U.S. Sta…

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA

by RemedyRePack Inc.

Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Published: January 1, 2025
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40

by Curium US, LLC

Reason: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Published: January 1, 2025
Distribution: Nationwide

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Data last updated: September 11, 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.