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Recall totals

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

37,115

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,793

Class I recallsReasonable probability of serious health consequences

24,343

Class II recallsTemporary or medically reversible health consequences

2,887

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/so-delicious-dairy-freer-issues-voluntary-recall-salted-caramel-cluster-non-dairy-frozen-dessertPublished September 15, 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 15, 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	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

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Recalls by class
Class	Recalls
Class II	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

FDA Recall United States Terminated Historical recordClass II

BUILT BRANDS LLC

Product: Peanut Butter Chocolate covered protein bars, packaged in me…
Reason: Products may be moldy prior to the end of the stated shelf life.
Published: August 5, 2020
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

BUILT BRANDS LLC

Product: Double Chocolate Mousse Chocolate covered protein bars, pack…
Reason: Products may be moldy prior to the end of the stated shelf life.
Published: August 5, 2020
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

BUILT BRANDS LLC

Product: Cookie Dough Chocolate covered protein bars, packaged in met…
Reason: Products may be moldy prior to the end of the stated shelf life.
Published: August 5, 2020
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

BUILT BRANDS LLC

Product: Cashew Caramel with Coconut Chocolate covered protein bars,…
Reason: Products may be moldy prior to the end of the stated shelf life.
Published: August 5, 2020
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

BUILT BRANDS LLC

Product: Banana Chocolate Creme Chocolate covered protein bars, packa…
Reason: Products may be moldy prior to the end of the stated shelf life.
Published: August 5, 2020
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

BUILT BRANDS LLC

Product: Banana Nut Bread Chocolate covered protein bars, packaged in…
Reason: Products may be moldy prior to the end of the stated shelf life.
Published: August 5, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antiseptic Hand Rub, Non-sterile Solution, Extra strength Formula*, 8.45 fl. oz. (250 ml) bottle, Labeled with green or blue labels, Manufactured by Mystic Intl S.A. de C.V. UPC barcode: 7 87790 33952 6

by Transliquid Technologies, LLC

Reason: Chemical Contamination: Presence of Undeclared Methanol
Published: July 29, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20

by Lupin Pharmaceuticals Inc.

Reason: Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Published: July 29, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10

by Fresenius Kabi USA, LLC

Reason: Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
Published: July 22, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg Size 15 patches per box, Insurance NDC: 53225-1025-01, Mfg: Terrain Pharmaceuticals; Reno, NV, Prod # (NDC): 68788-7405-01, Preferred Pharmaceuticals, Inc., The Physicians Solutions.

by Preferred Pharmaceuticals, Inc.

Reason: CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Published: July 22, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01.

by Keryx Biopharmaceuticals, Inc.

Reason: cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Published: July 22, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12

by Akorn, Inc.

Reason: Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Published: July 22, 2020
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India

by Granules Pharmaceuticals Inc

Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Published: July 22, 2020
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Garland Ventures, LTD DBA Bally Plus

Product: Freshness Guaranteed Five Cheese Stuffed Shells Traditional…
Reason: Potential contamination with Listeria monocytogenes
Published: July 22, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1

by EMD Serono, Inc.

Reason: Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Published: July 15, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01

by SOMERSET THERAPEUTICS LLC

Reason: Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Published: July 15, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01

by SOMERSET THERAPEUTICS LLC

Reason: Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Published: July 15, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01

by SOMERSET THERAPEUTICS LLC

Reason: Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Published: July 15, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01

by Flexion Therapeutics, Inc.

Reason: Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Published: July 8, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19.

by Glaxosmithkline Consumer Healthcare Holdings

Reason: Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Published: July 8, 2020
Distribution: Nationwide

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Data last updated: September 15, 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.