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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

Newest recallhttps://www.fsis.usda.gov/recalls-alerts/fontanini-foods-llc-recalls-raw-frozen-pork-sausage-products-due-possible-foreignPublished September 25, 2026

Most affected stateHawaii 200 recalls mention this state

State: HI ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 28, 2026 ET

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

Recalls by class
Class	Recalls
Class II	24,349
Class I	9,799
Class III	2,891
Not Yet Classified	1

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Recalls by class
Class	Recalls
Class II	24,349
Class I	9,799
Class III	2,891
Not Yet Classified	1

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

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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

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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

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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

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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

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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

DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-020-01

by Sato Pharmaceutical Inc.

Reason: Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Published: May 31, 2017
Distribution: US: Hawaii, Guam, Saipan, SPI

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FDA Recall Terminated Historical recordClass II

SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01

by Sato Pharmaceutical Inc.

Reason: Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Published: May 31, 2017
Distribution: US: Hawaii, Guam, Saipan, SPI

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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

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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

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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

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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

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FDA Recall Terminated Historical recordClass II

Nicardipine HCl 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

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FDA Recall Terminated Historical recordClass II

Phenylephrine HCl 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

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FDA Recall Terminated Historical recordClass II

Heparin sodium 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: September 28, 2026 ET

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.