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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 Ongoing Historical recordClass II

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10

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 Ongoing Historical recordClass II

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01

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 Ongoing Historical recordClass II

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-10

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 Ongoing Historical recordClass II

amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-50

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 Ongoing Historical recordClass II

amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08907 NDC 65162-178-09

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 Ongoing Historical recordClass II

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01

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

Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12

by Pfizer Inc.

Reason: Failed Dissolution Specifications
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30.

by Alembic Pharmaceuticals Limited

Reason: Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15

by Crown Laboratories

Reason: Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30

by Crown Laboratories

Reason: Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097

by A.P. Deauville, LLC

Reason: cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350

by QuVa Pharma, Inc.

Reason: Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sterile Curcumin 50mg/mL, 10 mL vial

by BIOTA Biosciences LLC

Reason: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial

by BIOTA Biosciences LLC

Reason: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial

by BIOTA Biosciences LLC

Reason: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sterile Curcumin, 4mg/mL, 10mL vial

by BIOTA Biosciences LLC

Reason: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial

by BIOTA Biosciences LLC

Reason: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass I

NOW Health Group Inc.

Product: NOW Real Food Raw Macadamia Nuts Unsalted 8 oz retail bag…
Reason: The product tested positive for Salmonella enterica.
Published: July 1, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0095-41

by Glaxosmithkline Consumer Healthcare Holdings

Reason: Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Published: June 24, 2020
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0574-41

by Glaxosmithkline Consumer Healthcare Holdings

Reason: Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Published: June 24, 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.