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Recall totals

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

37,113
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
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 5,941–5,960 of 18,020 recalls

FDA Recall Terminated Historical recordClass II

Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Published
September 29, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Published
September 29, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Published
September 29, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Published
September 29, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32

by Glenmark Pharmaceuticals Inc., USA

Reason
Lack of Assurance of Sterility
Published
September 29, 2021
Distribution
Nationwide

View recall →

FDA Recall Completed Historical recordClass I

X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2

by Phe Inc

Reason
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Published
September 29, 2021
Distribution
Nationwide

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FDA Recall Completed Historical recordClass II

Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16

by Morton Grove Pharmaceuticals, Inc.

Reason
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Published
September 29, 2021
Distribution
Nationwide

View recall →

FDA Recall Completed Historical recordClass II

Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16

by Morton Grove Pharmaceuticals, Inc.

Reason
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Published
September 29, 2021
Distribution
Nationwide

View recall →

FDA Recall Completed Historical recordClass II

Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16

by Morton Grove Pharmaceuticals, Inc.

Reason
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Published
September 29, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25

by American Health Packaging

Reason
Failed Impurities/Degradation Specifications
Published
September 29, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99

by Aurobindo Pharma USA Inc.

Reason
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Published
September 29, 2021
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023

by Pfizer Inc.

Reason
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Published
September 29, 2021
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-56.

by Pfizer Inc.

Reason
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Published
September 29, 2021
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56.

by Pfizer Inc.

Reason
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Published
September 29, 2021
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.

by Pfizer Inc.

Reason
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Published
September 29, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass I

AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17

by ICU Medical Inc

Reason
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Published
September 22, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy

by Prescription Labs Inc dba Greenpark

Reason
Lack of Assurance of Sterility
Published
September 22, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701

by Akorn, Inc.

Reason
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Published
September 22, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21

by Meitheal Pharmaceuticals Inc

Reason
Failed Impurities/Degradation Specifications
Published
September 22, 2021
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass I

Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.

by Teligent Pharma, Inc.

Reason
Superpotent Drug
Published
September 22, 2021
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.