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Recall totals

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

37,240
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,844
Class I recallsReasonable probability of serious health consequences
24,383
Class II recallsTemporary or medically reversible health consequences
2,897
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 2,084 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)

  • 1,739 recalls have been announced year to date.
  • Sep 2026 was 15% higher than the previous complete period (Aug 2026: 182).
  • The highest complete period was Jun 2026 (300).
  • 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 II24,383
Class I9,844
Class III2,897
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,383
Class I9,844
Class III2,897
Not Yet Classified2

Showing 20,381–20,400 of 23,278 recalls

FDA Recall TerminatedTerminated: April 7, 2017Historical recordClass III

Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

by Apotex Inc.

Reason
Subpotent drug
Published
May 20, 2015
Distribution
Nationwide

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FDA Recall TerminatedTerminated: April 7, 2017Historical recordClass III

Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

by Apotex Inc.

Reason
Subpotent drug
Published
May 20, 2015
Distribution
Nationwide

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FDA Recall TerminatedTerminated: February 14, 2017Historical recordClass III

Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.

by Cipla Limited

Reason
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Published
May 20, 2015
Distribution
Nationwide

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FDA Recall TerminatedTerminated: March 3, 2016Historical recordClass III

MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter, Distributed by INSIGHT Pharmaceuticals, LLC, Trevose, PA 19053-8433, NDC 63736-013-30

by Medtech Products, Inc.

Reason
Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.
Published
May 20, 2015
Distribution
Nationwide

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FDA Recall TerminatedTerminated: October 19, 2016Historical recordClass I

MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.

by Hospira Inc.

Reason
Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.
Published
May 20, 2015
Distribution
Nationwide

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FDA Recall TerminatedTerminated: June 5, 2018Historical recordClass II

Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Published
May 20, 2015
Distribution
New York

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FDA Recall TerminatedTerminated: June 5, 2018Historical recordClass II

Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Published
May 20, 2015
Distribution
New York

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FDA Recall TerminatedTerminated: June 5, 2018Historical recordClass II

Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Published
May 20, 2015
Distribution
New York

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FDA Recall TerminatedTerminated: June 5, 2018Historical recordClass II

Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Published
May 20, 2015
Distribution
New York

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FDA Recall TerminatedTerminated: June 5, 2018Historical recordClass II

Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Published
May 20, 2015
Distribution
New York

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FDA Recall TerminatedTerminated: June 5, 2018Historical recordClass II

Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Published
May 20, 2015
Distribution
New York

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FDA Recall TerminatedTerminated: June 5, 2018Historical recordClass II

Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Published
May 20, 2015
Distribution
New York

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FDA Recall TerminatedTerminated: June 5, 2018Historical recordClass II

Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Published
May 20, 2015
Distribution
New York

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FDA Recall TerminatedTerminated: June 5, 2018Historical recordClass II

Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Published
May 20, 2015
Distribution
New York

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FDA Recall TerminatedTerminated: June 5, 2018Historical recordClass II

Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Published
May 20, 2015
Distribution
New York

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FDA Recall TerminatedTerminated: January 26, 2017Historical recordClass II

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23

by Mission Pharmacal Co

Reason
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Published
May 20, 2015
Distribution
Nationwide

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FDA Recall TerminatedTerminated: January 26, 2017Historical recordClass II

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23

by Mission Pharmacal Co

Reason
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Published
May 20, 2015
Distribution
Nationwide

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FDA Recall TerminatedTerminated: July 13, 2018Historical recordClass II

Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15.

by Janssen Pharmaceuticals, Inc.

Reason
Subpotent Drug
Published
May 20, 2015
Distribution
Nationwide

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FDA Recall TerminatedTerminated: December 27, 2017Historical recordClass II

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

by Akorn, Inc.

Reason
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Published
May 20, 2015
Distribution
Nationwide

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FDA Recall TerminatedTerminated: December 27, 2017Historical recordClass II

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

by Akorn, Inc.

Reason
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Published
May 20, 2015
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.