FDA Recall United States Terminated Historical recordClass I
Wilton Industries Inc
- Product
- Wilton Holiday Mix Sprinkles, 7.6oz (215g) clear plastic bot…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
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Recall totals
All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.
37,115
Total recall recordsAll FDA and USDA recalls in Public Health Trace9,793
Class I recallsReasonable probability of serious health consequences24,343
Class II recallsTemporary or medically reversible health consequences2,887
Class III recallsNot likely to cause adverse health consequencesQuick 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/so-delicious-dairy-freer-issues-voluntary-recall-salted-caramel-cluster-non-dairy-frozen-dessertPublished September 15, 2026
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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A chart of recalls grouped by month.
Download CSVSummary (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
A bar chart of the total number of recalls in this dataset by recall class.
| Class | Recalls |
|---|---|
| Class II | 24,343 |
| Class I | 9,793 |
| Class III | 2,887 |
| Not Yet Classified | 1 |
| Class | Recalls |
|---|---|
| Class II | 24,343 |
| Class I | 9,793 |
| Class III | 2,887 |
| Not Yet Classified | 1 |
FDA Recall United States Terminated Historical recordClass I
Wilton Industries Inc
- Product
- Wilton Valentine Chip Crunch Sprinkles, 3.46 oz (98g) clear…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass I
Wilton Industries Inc
- Product
- Wilton Rainbow Chip Crunch Sprinkles, 5.25 oz (148g) clear p…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09
- Reason
- Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
- Published
- March 31, 2021
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6.
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
- Published
- March 31, 2021
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass I
Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
- Published
- March 31, 2021
- Distribution
- Nationwide
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
- Reason
- Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
- Published
- March 24, 2021
- Distribution
- Nationwide
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
- Reason
- Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
- Published
- March 24, 2021
- Distribution
- Nationwide
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
- 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
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.
- 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
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
- Reason
- Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
- Published
- March 24, 2021
- Distribution
- Nationwide
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
- Reason
- Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
- Published
- March 24, 2021
- Distribution
- Nationwide
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
- Reason
- Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
- Published
- March 24, 2021
- Distribution
- Nationwide
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.
- Reason
- Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
- Published
- March 17, 2021
- Distribution
- Nationwide
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
- 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
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)
- Reason
- Chemical contamination; Unknown brown residue adhering to the inside of one vial.
- Published
- March 10, 2021
- Distribution
- Nationwide
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.
- Reason
- Defective Delivery System: Out of specification for mechanical peel.
- Published
- March 10, 2021
- Distribution
- Nationwide
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.
- Reason
- Defective Delivery System: Out of specification for mechanical peel.
- Published
- March 10, 2021
- Distribution
- Nationwide
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.
- Reason
- Defective Delivery System: Out of specification for mechanical peel.
- Published
- March 10, 2021
- Distribution
- Nationwide
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.
- Reason
- Defective Delivery System: Out of specification for mechanical peel.
- Published
- March 10, 2021
- Distribution
- Nationwide
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.
