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Recall totals

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

37,135
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 11,161–11,180 of 17,237 recalls

FDA Recall Terminated Historical recordClass II

PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32

by SCA Pharmaceuticals

Reason
Lack of assurance of sterility: Product bags leaking at seam.
Published
June 7, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32

by SCA Pharmaceuticals

Reason
Lack of assurance of sterility: Product bags leaking at seam.
Published
June 7, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32

by SCA Pharmaceuticals

Reason
Lack of assurance of sterility: Product bags leaking at seam.
Published
June 7, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32

by SCA Pharmaceuticals

Reason
Lack of assurance of sterility: Product bags leaking at seam.
Published
June 7, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55

by SCA Pharmaceuticals

Reason
Lack of assurance of sterility: Product bags leaking at seam.
Published
June 7, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32

by SCA Pharmaceuticals

Reason
Lack of assurance of sterility: Product bags leaking at seam.
Published
June 7, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32

by SCA Pharmaceuticals

Reason
Lack of assurance of sterility: Product bags leaking at seam.
Published
June 7, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32

by SCA Pharmaceuticals

Reason
Lack of assurance of sterility: Product bags leaking at seam.
Published
June 7, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-55

by SCA Pharmaceuticals

Reason
Lack of assurance of sterility: Product bags leaking at seam.
Published
June 7, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.

by SCA Pharmaceuticals

Reason
Lack of assurance of sterility: Product bags leaking at seam.
Published
June 7, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.

by VistaPharm, Inc.

Reason
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Published
June 7, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

LaBri's Body Health Atomic, 60 capsules

by Envy Me

Reason
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
Published
May 31, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40

by Gentell, Inc

Reason
GMP Deviations; product may not meet cGMP requirements
Published
May 31, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottle, Manufactured for: Hyland's, Inc., Los Angesles, CA 90061, NDC 54973-3197-1, UPC 3 54973 31971 4.

by Standard Homeopathic Company

Reason
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Published
May 31, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.

by Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Reason
Superpotent Drug: above specification for the assay.
Published
May 31, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.

by Sun Pharmaceutical Industries, Inc.

Reason
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Published
May 31, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Published
May 31, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Published
May 31, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Published
May 31, 2017
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

by Advanced Pharma Inc.

Reason
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Published
May 31, 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.