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Research historical outbreak investigations and the full recall archive, with charts, trends, and advanced filters. Looking for what's happening right now instead? See current Health Alerts.

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 13,741–13,760 of 17,237 recalls

FDA Recall Terminated Historical recordClass III

Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured for Concordia Pharmaceuticals, Inc., St. Michael, Barbados BB11005, Manufactured by IriSys, LLC San Diego, CA 92121, Repackaged by: RxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10

by Rx PAK

Reason
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Published
October 28, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0073-1, UPC 0 5256913369 9

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, NDC 46122-0140-52, ABC# 059-535, UPC 0877014065546, Distributed by: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden Prarie, MN 55344 USA

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by: Drug Mart-Food Fair, Medina, OH 44256, UPC 0 93351 12101 2.

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO 64111; UPC 0 7003861209 4

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Published
October 21, 2015
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.