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Recall totals

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

37,142

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,799

Class I recallsReasonable probability of serious health consequences

24,349

Class II recallsTemporary or medically reversible health consequences

2,891

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 recallhttps://www.fsis.usda.gov/recalls-alerts/fontanini-foods-llc-recalls-raw-frozen-pork-sausage-products-due-possible-foreignPublished September 25, 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 27, 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	24,349
Class I	9,799
Class III	2,891
Not Yet Classified	1

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Recalls by class
Class	Recalls
Class II	24,349
Class I	9,799
Class III	2,891
Not Yet Classified	1

FDA Recall Terminated Historical recordClass II

Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11); 10 blister packs per carton (NDC 68084-505-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Published: July 15, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

by American Health Packaging

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Published: July 15, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.

by MYLAN PHARMACEUTICALS INC

Reason: Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Published: July 15, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.

by Hospira Inc.

Reason: Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Published: July 15, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India, NDC 60505-0209-1

by Apotex Inc.

Reason: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Published: July 15, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3161-9

by Apotex Inc.

Reason: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Published: July 15, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3162-9

by Apotex Inc.

Reason: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Published: July 15, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9

by Apotex Inc.

Reason: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Published: July 15, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.

by Bethel Nutritional Consulting, Inc

Reason: Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
Published: July 15, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11

by Teva Pharmaceuticals USA

Reason: Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Published: July 15, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99.

by Takeda Pharmaceuticals North America, Inc.

Reason: Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Published: July 8, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21.

by Qualitest Pharmaceuticals

Reason: Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.
Published: July 8, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., St. Louis, MO 63044, Distributed by Major Pharmaceuticals, Livonia, MI 48150, NDC 0904-6444-61.

by The Harvard Drug Group, LLC

Reason: Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
Published: July 8, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube, NDC 10578-035-05, b) 5 oz. Jar, NDC 10578-035-04, Manufactured by Indiana Botanic Gardens, Hobart, IN 46342

by Indiana Botanic Gardens, Inc

Reason: Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
Published: July 1, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc., Mississauga, Ontario L9N7K9 Canada, NDC 52544-0949-28

by Actavis Inc

Reason: Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Published: July 1, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01

by Bracco Diagnostic Inc

Reason: Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Published: July 1, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC 43598-316-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India

by Dr. Reddy's Laboratories, Inc.

Reason: Subpotent drug
Published: June 24, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90

by Dr. Reddy's Laboratories, Inc.

Reason: Subpotent drug
Published: June 24, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (NDC 43598-321-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India

by Dr. Reddy's Laboratories, Inc.

Reason: Subpotent drug
Published: June 24, 2015
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India

by Dr. Reddy's Laboratories, Inc.

Reason: Subpotent drug
Published: June 24, 2015
Distribution: Nationwide

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Data last updated: September 27, 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.