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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 14,021–14,040 of 18,028 recalls

FDA Recall Terminated Historical recordClass I

ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30.

by Medline Industries Inc

Reason
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Published
February 24, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)

by Amerisource Health Services

Reason
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Published
February 17, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540

by Sandoz Inc

Reason
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Published
February 17, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-9.

by Fagron, Inc

Reason
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Published
February 17, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1167-9.

by Fagron, Inc

Reason
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Published
February 17, 2016
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5.

by Fagron, Inc

Reason
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Published
February 17, 2016
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.

by Macleods Pharma Usa Inc

Reason
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Published
February 17, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157

by Perrigo Company PLC

Reason
Labeling: label error on declared strength.
Published
February 10, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.

by Perrigo Company PLC

Reason
Labeling: label error on declared strength.
Published
February 10, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21

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

Reason
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Published
February 10, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68

by Pfizer Inc.

Reason
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Published
February 10, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68

by Pfizer Inc.

Reason
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Published
February 10, 2016
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.

by Bausch & Lomb, Inc.

Reason
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Published
February 3, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.

by Bausch & Lomb, Inc.

Reason
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Published
February 3, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.

by Bausch & Lomb, Inc.

Reason
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Published
February 3, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217.

by Amerisource Health Services

Reason
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Published
February 3, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Published
February 3, 2016
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Published
February 3, 2016
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Published
February 3, 2016
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Published
February 3, 2016
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.