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Recall totals

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

37,139
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 11,001–11,020 of 19,206 recalls

FDA Recall Terminated Historical recordClass II

My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4.

by Lupin Pharmaceuticals Inc.

Reason
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Published
May 30, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.

by Lupin Pharmaceuticals Inc.

Reason
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Published
May 30, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8010.

by Ideaz Llc

Reason
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Published
May 30, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.

by Exela Pharma Sciences LLC

Reason
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
Published
May 30, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.

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

Reason
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Published
May 30, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20

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

Reason
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Published
May 30, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128

by AMA Wholesale

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Published
May 30, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8005.

by Ideaz Llc

Reason
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Published
May 30, 2018
Distribution
Nationwide

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FDA Recall United States Terminated Historical recordClass II

Grand Canyon Foods International LLC.

Product
Southwestern Gourmet Prickly Pear Popcorn Grand Canyon Foods…
Reason
An FDA inspection revealed products that contained Yellow 5 and soy lecithin failed to declare the presence of Yellow 5 and soy.
Published
May 30, 2018
Distribution
Product distributed to retail stores in…

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FDA Recall United States Terminated Historical recordClass II

Grand Canyon Foods International LLC.

Product
Southwestern Gourmet Butter Popcorn Grand Canyon Foods, Phoe…
Reason
An FDA inspection revealed products that contained Yellow 5 and soy lecithin failed to declare the presence of Yellow 5 and soy.
Published
May 30, 2018
Distribution
Product distributed to retail stores in…

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FDA Recall United States Terminated Historical recordClass II

Nature's Only Choice

Product
Nature's Only Choice B17 BITTER RAW APRICOT EXTRACT AMYGDALI…
Reason
The Vitamin B17 containing product is considered to be a prescription drug, new drug, and unapproved new drug.
Published
May 30, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30

by AuroMedics Pharma LLC

Reason
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Published
May 23, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4

by Apotex Inc.

Reason
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Published
May 23, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4

by Apotex Inc.

Reason
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Published
May 23, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02

by Sun Pharmaceutical Industries, Inc.

Reason
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Published
May 23, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02

by Perrigo New York

Reason
Failed Stability Specifications
Published
May 23, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010

by L. Perrigo Company

Reason
Defective delivery system
Published
May 23, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.

by Pharmalucence, Inc.

Reason
Failed Stability Specifications
Published
May 23, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA

by Boiron Inc.

Reason
Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
Published
May 23, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05

by Sun Pharmaceutical Industries, Inc.

Reason
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
Published
May 23, 2018
Distribution
Nationwide

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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.