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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
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 II24,349
Class I9,799
Class III2,891
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,349
Class I9,799
Class III2,891
Not Yet Classified1

Showing 14,401–14,420 of 20,519 recalls

FDA Recall Terminated Historical recordClass II

5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Published
March 22, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, Rx only, Synergy Rx, 4901 Morena Blvd #504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Published
March 22, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

KETOCONAZOLE 2%/HYDROCORTISONE 1.5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676.

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Published
March 22, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

HCG and HCG with resveratrol Human Chorionic Gonadotropin in different strengths: HCG 300 UNITS/RESVERATROL 50MG S.L. Tablet, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Published
March 22, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION, CANTHARIDIN/PODOPHYLLUM RESIN MIXTURE, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Published
March 22, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Published
March 22, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL), Colgate Oral Pharmaceuticals, Inc., New York, NY 10022 --- NDC 0126-0016-61, UPC 3834110622

by Colgate Palmolive Co

Reason
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Published
March 22, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21

by Amerisource Health Services

Reason
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Published
March 22, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road, Lincolnton, NC 28092.

by G & W Laboratories, Inc.

Reason
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Published
March 22, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1

by Isomeric Pharmacy Solution, LLC

Reason
CGMP Deviations
Published
March 22, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications
Published
March 22, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany, MADE IN FRANCE; packaged in A) Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51) in a) bundles of 10 unit cartons (NDC 0008-0923-55) and b) 25 x 40 mg Vials per carton (NDC 0008-0923-60); B) NOVAPLUS, 1 vial per carton (NDC 00008-0941-01) in 25 x 40 mg Vials per carton (NDC 0008-0941-03); and C) PREMIERPro Rx, 1 vial per carton (NDC 0008-4001-01) in a) bundles of 10 unit cartons (NDC 0008-4001-10) and b) 25 x 40 mg Vials per carton (NDC 0008-4001-25).

by Pfizer Inc.

Reason
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Published
March 22, 2017
Distribution
Nationwide

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FDA Recall United States Terminated Historical recordClass I

Gel Spice Co, Inc.

Product
1) Ground Tumeric item #73535 Net Wt 50 lbs Distributed by…
Reason
Ground Turmeric may contain excess levels of lead.
Published
March 22, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31

by Sandoz Inc

Reason
Failed Dissolution Specifications
Published
March 15, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05

by Actavis Inc

Reason
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Published
March 15, 2017
Distribution
Nationwide

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FDA Recall Completed Historical recordClass II

Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01.

by Mckesson Packaging Services

Reason
Presence of Foreign Substance: foreign material found in the bulk inventory.
Published
March 15, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02.

by Endo Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Published
March 15, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Published
March 15, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040

by LEO PHARMA INC

Reason
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Published
March 15, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Published
March 15, 2017
Distribution
Nationwide

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.