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Recall totals

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

37,204
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,841
Class I recallsReasonable probability of serious health consequences
24,366
Class II recallsTemporary or medically reversible health consequences
2,892
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 2,073 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)

  • 1,714 recalls have been announced year to date.
  • Sep 2026 was 3% higher than the previous complete period (Aug 2026: 182).
  • The highest complete period was Jun 2026 (297).
  • Oct 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 II24,366
Class I9,841
Class III2,892
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,366
Class I9,841
Class III2,892
Not Yet Classified2

Showing 16,581–16,600 of 17,350 recalls

FDA Recall Terminated Historical recordClass II

Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2

by Kareway Product Inc

Reason
Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
Published
July 3, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Published
July 3, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Published
July 3, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Published
July 3, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Published
July 3, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Published
July 3, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Published
July 3, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-02

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Published
July 3, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Published
July 3, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Published
July 3, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.

by Hill Dermaceuticals, Inc.

Reason
Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Published
July 3, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage diluent container, Distributed by Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017, NDC a) 0009-3124-03 and b) 0009-3447-03

by Pharmacia & Upjohn LLC

Reason
Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
Published
June 26, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02

by Hospira Inc.

Reason
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Published
June 26, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017.

by PFIZER INC

Reason
Failed Dissolution Specification
Published
June 26, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.

by Sagent Pharmaceuticals Inc

Reason
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
Published
June 26, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16

by Hi-Tech Pharmacal Co., Inc.

Reason
Subpotent; 24 month stability test station
Published
June 26, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE

by Mission Pharmacal Co

Reason
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Published
June 26, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013

by Advance Pharmaceutical Inc

Reason
Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
Published
June 19, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL

by OLAAX International

Reason
Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Published
June 19, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.

by Actavis

Reason
Failed Impurities/Degradation Specifications
Published
June 19, 2013
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.