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Recall totals

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

36,950
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,732
Class I recallsReasonable probability of serious health consequences
24,263
Class II recallsTemporary or medically reversible health consequences
2,873
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 2,071 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)

  • 1,458 recalls have been announced year to date.
  • Aug 2026 was 53% 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 II24,263
Class I9,732
Class III2,873
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,263
Class I9,732
Class III2,873
Not Yet Classified1

Showing 1,041–1,060 of 18,300 recalls

FDA Recall Ongoing Historical recordClass II

Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Published
September 17, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Published
September 17, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Published
September 17, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Published
September 17, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Published
September 17, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Published
September 17, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Published
September 17, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1130-1

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Published
September 17, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Published
September 17, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Published
September 17, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters).

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Published
September 17, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Published
September 17, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)

by Exela Pharma Sciences LLC

Reason
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Published
September 17, 2025
Distribution
Nationwide

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FDA Recall United States Ongoing Historical recordClass II

M.O.M Enterprises, LLC.

Product
Organic BABY bedtime drops; sleep + immunity blend; Promotes…
Reason
Potential for spoilage due to yeast contamination.
Published
September 17, 2025
Distribution
Multiple states

View recall →

FDA Recall United States Terminated Historical recordClass III

Dynamic Sports Nutrition

Product
Anabolic Research WINN-50 (vanazolol). Dietary Supplement.…
Reason
Dietary supplement involved degradation of an ingredient. Product is sub-potent for Vitamin B12 not meeting label claims.
Published
September 17, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass I

0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09

by B BRAUN MEDICAL INC

Reason
Presence of Particulate Matter.
Published
September 10, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass I

Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07

by B BRAUN MEDICAL INC

Reason
Presence of Particulate Matter
Published
September 10, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.

by Amneal Pharmaceuticals, LLC

Reason
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Published
September 10, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.

by Amneal Pharmaceuticals, LLC

Reason
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Published
September 10, 2025
Distribution
Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.

by Amneal Pharmaceuticals, LLC

Reason
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Published
September 10, 2025
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.