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Recall totals

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

37,066
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
Most affected stateHawaii 200 recalls mention this state

Download matching recalls as CSV

CSV exports include up to 5,000 matching rows (applying your current filters), not the full dataset if it's larger.

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Recalls announced by month (Year to date)

A chart of recalls grouped by month.

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Source: FDA and USDA public dataLast updated

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

A bar chart of the total number of recalls in this dataset by recall class.

Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2

Showing 3,021–3,040 of 22,291 recalls

FDA Recall Terminated Historical recordClass III

Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06

by Acella Pharmaceuticals, LLC

Reason
Subpotent drug
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762

by RemedyRePack Inc.

Reason
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00

by Rubicon Research Private Limited

Reason
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass I

Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.

by Dr. Reddy's Laboratories, Inc.

Reason
Sub-potent Drug; powder discoloration associated with decreased potency
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass I

Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.

by Dr. Reddy's Laboratories, Inc.

Reason
Sub-potent Drug; powder discoloration associated with decreased potency
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.

by Breckenridge Pharmaceutical, Inc

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.

by Breckenridge Pharmaceutical, Inc

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

by Breckenridge Pharmaceutical, Inc

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Published
May 15, 2024
Distribution
Nationwide

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FDA Recall United States Terminated Historical recordClass I

Belgian Yummies

Product
Belgian Yummies Homemade Ice Cream Horchata Gelato. Package…
Reason
Undeclared Allergen: milk and wheat.
Published
May 15, 2024
Distribution
The products were only distributed in th…

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FDA Recall United States Terminated Historical recordClass I

Belgian Yummies

Product
Salted Caramel Ice Cream Cookie Sandwich. Sandwiches package…
Reason
Undeclared Allergen: milk, eggs, soy, wheat, peanuts, and tree nuts.
Published
May 15, 2024
Distribution
The products were only distributed in th…

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FDA Recall United States Terminated Historical recordClass I

Belgian Yummies

Product
Raspberry Ice Cream Cookie Sandwich. Sandwiches packaged in…
Reason
Undeclared Allergen: milk,eggs, wheat, peanuts, and tree nuts.
Published
May 15, 2024
Distribution
The products were only distributed in th…

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FDA Recall United States Terminated Historical recordClass I

Belgian Yummies

Product
Chocolate Ice Cream Cookie Sandwich. Sandwiches packaged in…
Reason
Undeclared Allergen: milk, eggs, wheat, peanuts, and tree nuts.
Published
May 15, 2024
Distribution
The products were only distributed in th…

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FDA Recall United States Terminated Historical recordClass II

Belgian Yummies

Product
Belgian Yummies Homemade Ice Cream Birthday Cake Gelato. P…
Reason
Undeclared Allergen: Yellow #5
Published
May 15, 2024
Distribution
The products were only distributed in th…

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FDA Recall United States Terminated Historical recordClass II

Belgian Yummies

Product
Belgian Yummies Homemade Ice Cream Strawberry Gelato. Pack…
Reason
Undeclared Allergens: Yellow # 5
Published
May 15, 2024
Distribution
The products were only distributed in th…

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FDA Recall United States Terminated Historical recordClass III

HTO Nevada Inc DBA Kirkman

Product
Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule diet…
Reason
Labeling error. The 5-MTHF 1mg label incorrectly declares 5000mcg Folic Acid instead 1000mcg Folic Acid per serving in the Supplement Facts, but correctly declares Folate 1667mcg DFE. The front label correctly declares product as 5-MTHF Methyltetrahydrofolate 1mg (or 1000mcg).
Published
May 15, 2024
Distribution
Distributed in CA, FL, OH, TX, WA and WI…

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FDA Recall United States Ongoing Historical recordClass II

Sacramento Cookie Factory

Product
Original Wine Wafer - Lemon Vanilla [Two sizes: retail packa…
Reason
Undeclared allergen (milk)
Published
May 15, 2024
Distribution
U.S. Distribution to the following state…

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FDA Recall United States Ongoing Historical recordClass II

Sacramento Cookie Factory

Product
Tea Wafer - Vanilla Almond [Two sizes: retail package of 8 w…
Reason
Undeclared allergen (milk)
Published
May 15, 2024
Distribution
U.S. Distribution to the following state…

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FDA Recall United States Ongoing Historical recordClass II

Sacramento Cookie Factory

Product
Java Wafer - Mocha Hazelnut [Two sizes: retail package of 8…
Reason
Undeclared allergen (milk)
Published
May 15, 2024
Distribution
U.S. Distribution to the following state…

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FDA Recall United States Terminated Historical recordClass I

Belgian Yummies

Product
Peanut Butter Ice Cream Cookie Sandwich. Sandwiches packaged…
Reason
Undeclared Allergen: milk, eggs, wheat, peanuts, and tree nuts.
Published
May 15, 2024
Distribution
The products were only distributed in th…

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FDA Recall United States Terminated Historical recordClass I

Belgian Yummies

Product
Key Lime Ice Cream Cookie Sandwich. Sandwiches packaged in a…
Reason
Undeclared Allergen: milk, eggs, soy, wheat, peanuts, and tree nuts.
Published
May 15, 2024
Distribution
The products were only distributed in th…

View recall →

Data last updated:

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.