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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: PR ×
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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 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

Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.

by VistaPharm, Inc.

Reason: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Published: July 15, 2020
Distribution: United States including Puerto Rico

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FDA Recall Terminated Historical recordClass III

Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.

by VistaPharm, Inc.

Reason: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Published: July 15, 2020
Distribution: United States including Puerto Rico

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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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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.