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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: AS ×
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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

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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FDA Recall Ongoing Historical recordClass I

ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.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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FDA Recall Ongoing Historical recordClass I

PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.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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FDA Recall Ongoing Historical recordClass I

VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.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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FDA Recall Ongoing Historical recordClass II

Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons).

by American Regent, Inc.

Reason: Presence of Particulate Matter: Potential for glass delamination from the vials.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).

by American Regent, Inc.

Reason: Presence of Particulate Matter: Potential for glass delamination from the vials.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).

by American Regent, Inc.

Reason: Presence of Particulate Matter: Potential for glass delamination from the vials.
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05

by Aurobindo Pharma USA Inc

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

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FDA Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

by Aurobindo Pharma USA Inc

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

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FDA Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

by Aurobindo Pharma USA Inc

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

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FDA Recall Ongoing Historical recordClass II

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17

by ACCORD HEALTHCARE, INC.

Reason: Subpotent drug
Published: December 11, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05

by JR Watkins

Reason: cGMP Deviations
Published: December 4, 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.