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Recall totals

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

37,060

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,786

Class I recallsReasonable probability of serious health consequences

24,313

Class II recallsTemporary or medically reversible health consequences

2,876

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/freshpoint-issues-recall-due-improperly-declared-allergen-egg-chicken-salad-wedge-sandwichesPublished September 8, 2026

Most affected stateHawaii 200 recalls mention this state

State: VI ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 9, 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	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

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Recalls by class
Class	Recalls
Class II	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

FDA Recall United States Ongoing Historical recordClass II

Tropicale Foods, LLC

Product: La Michoacana Coconut Con Crema Single Serve Paleta 3.75oz U…
Reason: Product label includes the ingredient CREAM but does not include Milk as the source.
Published: August 20, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass III

Enjoy Nutrition, LLC; dba Weyland Brain Nutrition

Product: Lithium Orotate, 10MG, Distributed by Enjoy Nutrition, LLC.…
Reason: Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Published: August 20, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass III

Enjoy Nutrition, LLC; dba Weyland Brain Nutrition

Product: Lithium Orotate, 5MG, Distributed by Enjoy Nutrition, LLC. U…
Reason: Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Published: August 20, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

Superior Foods Company

Product: Park Street Deli Cinnamon Bun Dessert Dip Net WT 7oz. in pla…
Reason: foreign material (plastic)
Published: August 20, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Presence of foreign substance: identified as aluminum.
Published: August 13, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01

by Cardinal Health Inc.

Reason: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Published: August 13, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

by Cardinal Health Inc.

Reason: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Published: August 13, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.

by Cardinal Health Inc.

Reason: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Published: August 13, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,

by Direct Rx

Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Published: August 13, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30

by Direct Rx

Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Published: August 13, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31

by Alembic Pharmaceuticals Limited

Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Published: August 13, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Published: August 13, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

QUEEN BEE GARDENS

Product: Brand Name: Queen Bee Gardens Whipped Honey Huckleberry Inte…
Reason: Product may have small flakes of stainless steel in product.
Published: August 13, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

QUEEN BEE GARDENS

Product: Brand Name: Queen Bee Gardens Whipped Honey Pure. Intended u…
Reason: Product may have small flakes of stainless steel in product.
Published: August 13, 2025
Distribution: Nationwide

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FDA Recall United States Terminated Historical recordClass II

QUEEN BEE GARDENS

Product: Brand Name: Queen Bee Gardens Whipped Honey Raspberry. Inte…
Reason: Product may have small flakes of stainless steel in product.
Published: August 13, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25

by Hikma Pharmaceuticals USA Inc.

Reason: Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Published: August 6, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.

by Nostrum Laboratories, Inc.

Reason: CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Published: August 6, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04

by Strides Pharma, Inc.

Reason: Failed Dissolution Specifications.
Published: August 6, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04

by Pfizer Inc.

Reason: CGMP Deviations; particulates identified during visual inspection
Published: August 6, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02

by Pfizer Inc.

Reason: CGMP Deviations; particulates identified during visual inspection
Published: August 6, 2025
Distribution: Nationwide

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Data last updated: September 9, 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.