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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.

37,118
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,793
Class I recallsReasonable probability of serious health consequences
24,343
Class II recallsTemporary or medically reversible health consequences
2,887
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 recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gf-blends-recalls-truly-aip-all-purpose-flour-and-bread-mix-and-eat-gangster-flat-bread-pizza-mixPublished September 18, 2026
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 II24,343
Class I9,793
Class III2,887
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,343
Class I9,793
Class III2,887
Not Yet Classified1

Showing 8,421–8,440 of 18,163 recalls

FDA Recall Terminated Historical recordClass II

Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01

by Piramal Critical Care, Inc.

Reason
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
Published
August 7, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1

by LNK International, Inc.

Reason
Microbial contamination of non-sterile product
Published
August 7, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.

by MAJOR PHARMACEUTICALS

Reason
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Published
August 7, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11

by American Health Packaging

Reason
Failed Dissolution Specifications: Out of specification result for the dissolution test.
Published
August 7, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979

by ImprimisRx NJ

Reason
Subpotent Drug
Published
August 7, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979

by ImprimisRx NJ

Reason
Subpotent Drug
Published
August 7, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Published
August 7, 2019
Distribution
Multiple states

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FDA Recall Terminated Historical recordClass II

Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Published
August 7, 2019
Distribution
Multiple states

View recall →

FDA Recall Terminated Historical recordClass II

Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Published
August 7, 2019
Distribution
Multiple states

View recall →

FDA Recall Terminated Historical recordClass II

Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Published
August 7, 2019
Distribution
Multiple states

View recall →

FDA Recall Terminated Historical recordClass II

Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Published
August 7, 2019
Distribution
Multiple states

View recall →

FDA Recall Terminated Historical recordClass II

Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Published
August 7, 2019
Distribution
Multiple states

View recall →

FDA Recall Terminated Historical recordClass II

Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Published
August 7, 2019
Distribution
Multiple states

View recall →

FDA Recall Terminated Historical recordClass II

Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Published
August 7, 2019
Distribution
Multiple states

View recall →

FDA Recall Terminated Historical recordClass II

Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Published
August 7, 2019
Distribution
Multiple states

View recall →

FDA Recall Terminated Historical recordClass II

Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Published
August 7, 2019
Distribution
Multiple states

View recall →

FDA Recall Terminated Historical recordClass II

Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Published
August 7, 2019
Distribution
Multiple states

View recall →

FDA Recall Terminated Historical recordClass II

Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton of 3 wallets)

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Published
August 7, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Published
July 31, 2019
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.

by Dercher Enterprises, Inc., DBA Gordon Laboratories

Reason
Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
Published
July 31, 2019
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.