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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: MP ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 16, 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 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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FDA Recall Terminated Historical recordClass II

Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12.

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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FDA Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61

by The Harvard Drug Group

Reason: CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Published: July 8, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665

by Beaming White Llc

Reason: Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Published: July 8, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665

by Beaming White Llc

Reason: Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Published: July 8, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665

by Beaming White Llc

Reason: Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Published: July 8, 2020
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

Beyond Better Foods Llc

Product: Enlightened Dairy-Free Chocolate Peanut Butter Frozen Desser…
Reason: Product may contain undeclared milk. Chocolate Peanut Butter ice cream may be filled in pint sized Dairy-Free Chocolate Peanut Butter containers that have a lid labeled Chocolate Peanut Butter without the "Dairy-Free" callout.
Published: July 8, 2020
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

Trident Seafoods Corporation

Product: Gordon Choice Imitation Crab Supreme Style, Net Wt 40 oz (2…
Reason: Product may contain undeclared egg white.
Published: July 8, 2020
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

Mount Franklin Foods LLC

Product: 7-Select Yogurt Pretzels Naturally Flavored Vanilla Crunchy…
Reason: Potential to contain undeclared peanuts
Published: July 8, 2020
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Brill Inc

Product: Brill 30 lb. cases of 480 1.0 oz. chocolate chip with mini c…
Reason: Products may contain undeclared walnuts.
Published: July 8, 2020
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90

by Amneal Pharmaceuticals of New York, LLC

Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11

by American Health Packaging

Reason: Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05

by Aurobindo Pharma USA Inc.

Reason: Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Waluj, Aurangabad - 431-136 Maharashtra, India, NDC 64980-513-05

by Rising Pharmaceuticals, Inc.

Reason: Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Industrial Area, Waluj, Aurangbad - 431 136 Marahastra, India, NDC 64980-514-05

by Rising Pharmaceuticals, Inc.

Reason: Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Published: July 1, 2020
Distribution: Nationwide

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Data last updated: September 16, 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.