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

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Source: FDA and USDA public dataLast updated September 28, 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

AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10

by Burel Pharmaceuticals Inc

Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10

by Burel Pharmaceuticals Inc

Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-300-10

by Burel Pharmaceuticals Inc

Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS

by Burel Pharmaceuticals Inc

Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90

by Burel Pharmaceuticals Inc

Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977

by Par Pharmaceutical, Inc.

Reason: Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

purely elizabeth.

Product: Chocolate Sea Salt Probiotic Granola, Purely Elizabeth, 8oz,…
Reason: Chocolate Sea Salt Probiotic Granola due to undeclared soy lecithin.
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Island Soups Company Inc.

Product: ISLAND SOUPS, FISH SOUP, NET WT. 16 OZ (28.4G)
Reason: Possible contamination with Clostridium botulinum
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Island Soups Company Inc.

Product: ISLAND SOUPS, RED PEAS SOUP, NET WT. 16 OZ (28.4G)
Reason: Possible contamination with Clostridium botulinum
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Island Soups Company Inc.

Product: ISLAND SOUPS, RED PEAS SOUP NO MEAT, NET WT. 16 OZ (28.4G)
Reason: Possible contamination with Clostridium botulinum
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Island Soups Company Inc.

Product: ISLAND SOUPS, GUNGO PEAS SOUP, NET WT. 16 OZ (28.4G)
Reason: Possible contamination with Clostridium botulinum
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Island Soups Company Inc.

Product: ISLAND SOUPS, GUNGO PEAS SOUP NO MEAT, NET WT. 16 OZ (28.4G)
Reason: Possible contamination with Clostridium botulinum
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Island Soups Company Inc.

Product: ISLAND SOUPS, MANNISH WATER, NET WT. 16 OZ (28.4G)
Reason: Possible contamination with Clostridium botulinum
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Rosa Foods HQ

Product: Soylent Food Bars, Net Wt. 2.12 oz (60g), 12 pack.
Reason: Rosa Foods is recalling Soylent Bar because a number of their customers have experienced gastrointestinal issues after consuming Soylent Bars.
Published: December 7, 2016
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01

by West-Ward Pharmaceuticals Corp.

Reason: Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Published: November 30, 2016
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32

by Hospira Inc.

Reason: Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Published: November 30, 2016
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY

by Akorn Inc

Reason: Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Published: November 30, 2016
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA

by Mylan Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications: OOS results for known compound.
Published: November 30, 2016
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01

by Pfizer Inc.

Reason: Superpotent
Published: November 30, 2016
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05

by Zydus Pharmaceuticals USA Inc

Reason: Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Published: November 30, 2016
Distribution: Nationwide

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Data last updated: September 28, 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.