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Recall totals

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

37,066

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/whole-foods-market-issues-allergy-alert-undeclared-egg-cabricharme-cheesePublished September 11, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 12, 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

Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Published: May 15, 2024
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass III

HTO Nevada Inc DBA Kirkman

Product: Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule diet…
Reason: Labeling error. The 5-MTHF 1mg label incorrectly declares 5000mcg Folic Acid instead 1000mcg Folic Acid per serving in the Supplement Facts, but correctly declares Folate 1667mcg DFE. The front label correctly declares product as 5-MTHF Methyltetrahydrofolate 1mg (or 1000mcg).
Published: May 15, 2024
Distribution: Distributed in CA, FL, OH, TX, WA and WI…

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FDA Recall United States Ongoing Historical recordClass II

Sacramento Cookie Factory

Product: Original Wine Wafer - Lemon Vanilla [Two sizes: retail packa…
Reason: Undeclared allergen (milk)
Published: May 15, 2024
Distribution: U.S. Distribution to the following state…

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FDA Recall United States Ongoing Historical recordClass II

Sacramento Cookie Factory

Product: Tea Wafer - Vanilla Almond [Two sizes: retail package of 8 w…
Reason: Undeclared allergen (milk)
Published: May 15, 2024
Distribution: U.S. Distribution to the following state…

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FDA Recall United States Ongoing Historical recordClass II

Sacramento Cookie Factory

Product: Java Wafer - Mocha Hazelnut [Two sizes: retail package of 8…
Reason: Undeclared allergen (milk)
Published: May 15, 2024
Distribution: U.S. Distribution to the following state…

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FDA Recall United States Terminated Historical recordClass II

S Martinelli & Company

Product: Martinelli's Gold Medal Apple Juice From U.S. Grown Fresh Ap…
Reason: Elevated levels of inorganic arsenic.
Published: May 15, 2024
Distribution: U.S. distribution to the following: AL,…

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FDA Recall United States Ongoing Historical recordClass II

Sacramento Cookie Factory

Product: California Wine Wafer - Mocha Chocolate and Original Wine Wa…
Reason: Undeclared allergen (milk)
Published: May 15, 2024
Distribution: U.S. Distribution to the following state…

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FDA Recall United States Ongoing Historical recordClass II

Sacramento Cookie Factory

Product: Champagne Wafer - Raspberry Almond [Two sizes: retail packag…
Reason: Undeclared allergen (milk)
Published: May 15, 2024
Distribution: U.S. Distribution to the following state…

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FDA Recall Completed Historical recordClass III

Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77

by Viatris Inc

Reason: Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Published: May 8, 2024
Distribution: Nationwide

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FDA Recall Completed Historical recordClass III

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05

by Hikma Injectables USA Inc

Reason: Labeling: Wrong Barcode
Published: May 8, 2024
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01

by Regeneron Pharmaceuticals Inc

Reason: Lack of Assurance of Sterility: Complaints of syringe breakage
Published: May 8, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01

by Imprimis NJOF, LLC

Reason: Out of specification for assay
Published: May 8, 2024
Distribution: Nationwide

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FDA Recall Completed Historical recordClass II

Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.

by Amneal Pharmaceuticals of New York, LLC

Reason: Failed Dissolution Specifications
Published: May 8, 2024
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08

by Imprimis NJOF, LLC

Reason: Subpotent Drug
Published: May 8, 2024
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

INTERNATIONAL PITA BREAD, INC.

Product: International Bread Pita Chips Retail Clamshell Container: 1…
Reason: Label declares flour as an ingredient but does not declare sub-ingredients (wheat).
Published: May 8, 2024
Distribution: U.S. distribution to the following: CA…

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FDA Recall United States Terminated Historical recordClass II

INTERNATIONAL PITA BREAD, INC.

Product: International Bread Pita Chips Retail Clamshell Container: 1…
Reason: Label declares flour as an ingredient but does not declare sub-ingredients (wheat).
Published: May 8, 2024
Distribution: U.S. distribution to the following: CA…

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FDA Recall United States Terminated Historical recordClass II

BF Suma Pharmaceuticals, Inc.

Product: Longreen Corporation Xlim Express Coffee, 15 grams/sachet, 1…
Reason: Undeclared allergens due to sub-ingredients, soy lecithin and coconut oil
Published: May 8, 2024
Distribution: U.S. distribution to the following state…

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FDA Recall United States Terminated Historical recordClass II

BF Suma Pharmaceuticals, Inc.

Product: Longreen Corporation 4 in1 Cordyceps Coffee, 18.2 grams/sach…
Reason: Undeclared allergens due to sub-ingredients, soy lecithin and coconut oil
Published: May 8, 2024
Distribution: U.S. distribution to the following state…

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FDA Recall United States Terminated Historical recordClass II

BF Suma Pharmaceuticals, Inc.

Product: Longreen Corporation 4 in1 Reishi Coffee, 18.2 grams/sachet,…
Reason: Undeclared allergens due to sub-ingredients, soy lecithin and coconut oil
Published: May 8, 2024
Distribution: U.S. distribution to the following state…

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Data last updated: September 12, 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.