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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 6,001–6,020 of 17,327 recalls

FDA Recall Terminated Historical recordClass III

Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01

by Teva Pharmaceuticals USA

Reason
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Published
March 24, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10

by Breckenridge Pharmaceutical, Inc

Reason
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Published
March 24, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05

by Edge Pharma, LLC

Reason
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Published
March 24, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01.

by Sagent Pharmaceuticals Inc

Reason
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Published
March 24, 2021
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01

by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Reason
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Published
March 24, 2021
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass I

Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA

by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Reason
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Published
March 24, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Published
March 24, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-2; b) Professional Sample Kit: 3 single dose vials of Menotropins for injection, 3 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-3; Rx Only, Manufactured for Ferring Pharmaceuticals Inc. Parsippany. NJ 07054. Diluent manufactured for Ferring Pharmaceuticals Inc.

by Ferring Pharmaceuticals Inc

Reason
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Published
March 17, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
Published
March 10, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray)

by Teva Pharmaceuticals USA

Reason
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Published
March 10, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5555-3.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for mechanical peel.
Published
March 10, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5554-3.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for mechanical peel.
Published
March 10, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5553-3.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for mechanical peel.
Published
March 10, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for mechanical peel.
Published
March 10, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Published
March 10, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Published
March 10, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Subpotent
Published
March 10, 2021
Distribution
Nationwide

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FDA Recall United States Terminated Historical recordClass III

Ferrara Candy Company

Product
Ferrara Candy Company assorted candy Heart Box, including La…
Reason
Undeclared ingredients on retail packaging, including but not limited to certified colors Red #40 and Blue #1
Published
March 10, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06), Rx only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631.

by Meitheal Pharmaceuticals Inc

Reason
Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
Published
March 3, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Published
March 3, 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.