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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.

37,066
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,786
Class I recallsReasonable probability of serious health consequences
24,313
Class II recallsTemporary or medically reversible health consequences
2,876
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/whole-foods-market-issues-allergy-alert-undeclared-egg-cabricharme-cheesePublished September 11, 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 II24,313
Class I9,786
Class III2,876
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2

Showing 3,121–3,140 of 18,528 recalls

FDA Recall Ongoing Historical recordClass II

Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213

by New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Reason
Lack of Assurance of Sterility
Published
August 2, 2023
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807

by Kramer Laboratories, Inc.

Reason
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Published
August 2, 2023
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807

by Kramer Laboratories, Inc.

Reason
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Published
August 2, 2023
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12

by ALEMBIC PHARMACEUTICALS, INC.

Reason
Defective Delivery System
Published
August 2, 2023
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Presence of Foreign Substance: Metal embedded in a tablet.
Published
August 2, 2023
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.

by Sagent Pharmaceuticals

Reason
Lack of Assurance of Sterility
Published
August 2, 2023
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.

by Sagent Pharmaceuticals

Reason
Lack of Assurance of Sterility
Published
August 2, 2023
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.

by Sagent Pharmaceuticals

Reason
Lack of Assurance of Sterility
Published
August 2, 2023
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.

by Glenmark Therapeutics, Inc.

Reason
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Published
July 26, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Published
July 26, 2023
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Published
July 26, 2023
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Published
July 26, 2023
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Published
July 26, 2023
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Published
July 26, 2023
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;

by New England Life Care, Inc. dba Advanced Compounding Solutions

Reason
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Published
July 26, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05

by New England Life Care, Inc. dba Advanced Compounding Solutions

Reason
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Published
July 26, 2023
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;

by New England Life Care, Inc. dba Advanced Compounding Solutions

Reason
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Published
July 26, 2023
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10

by New England Life Care, Inc. dba Advanced Compounding Solutions

Reason
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Published
July 26, 2023
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30.

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications
Published
July 26, 2023
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Published
July 26, 2023
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.