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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: ND ×
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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

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30

by AvKARE

Reason: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ

by Rising Pharma Holding, Inc.

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ

by Rising Pharma Holding, Inc.

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

by Rising Pharma Holding, Inc.

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28

by AvKARE

Reason: Labeling: Label Mix-Up
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28

by AvKARE

Reason: Labeling: Label Mix-Up
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets

by Zydus Pharmaceuticals (USA) Inc

Reason: Labeling: Not Elsewhere Classified - Wrong NDC number
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-554-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670

by Midlab Incorporated

Reason: cGMP Deviations: Out of specification results for micro in hand soap products.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339

by Midlab Incorporated

Reason: cGMP Deviations: Out of specification results for micro in hand soap products.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139

by Midlab Incorporated

Reason: cGMP Deviations: Out of specification results for micro in hand soap products.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509

by Midlab Incorporated

Reason: cGMP Deviations: Out of specification results for micro in hand soap products.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015

by Midlab Incorporated

Reason: cGMP Deviations: Out of specification results for micro in hand soap products.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303

by Midlab Incorporated

Reason: cGMP Deviations: Out of specification results for micro in hand soap products.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass I

ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com

by Boulla LLC

Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Published: December 11, 2024
Distribution: Nationwide

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Data last updated: September 9, 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.