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Recall totals

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

37,204

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,841

Class I recallsReasonable probability of serious health consequences

24,366

Class II recallsTemporary or medically reversible health consequences

2,892

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 2,073 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sierra-nevada-cheese-company-recalls-graziers-raw-milk-cheese-because-possible-health-riskPublished September 28, 2026

Most affected stateHawaii 200 recalls mention this state

State: AS ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 30, 2026 ET

Summary (Year to date)

1,714 recalls have been announced year to date.
Sep 2026 was 3% higher than the previous complete period (Aug 2026: 182).
The highest complete period was Jun 2026 (297).

Recalls by class

Recalls by class
Class	Recalls
Class II	24,366
Class I	9,841
Class III	2,892
Not Yet Classified	2

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Recalls by class
Class	Recalls
Class II	24,366
Class I	9,841
Class III	2,892
Not Yet Classified	2

FDA Recall Terminated Historical recordClass III

Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2081-24

by Novartis Consumer Health

Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Published: January 22, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2084-24.

by Novartis Consumer Health

Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Published: January 22, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24.

by Novartis Consumer Health

Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Published: January 22, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01

by Sigma-Tau Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of Oncaspar Injection, because of a crack under the crimp seal which caused a leak.
Published: January 22, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-556-09

by Lupin Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Published: January 22, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24). Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.

by Novartis Consumer Health

Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Published: January 22, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2082-32.

by Novartis Consumer Health

Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Published: January 22, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977, NDC 59762-6692-8

by Greenstone Llc

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months.
Published: January 22, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.

by Hospira Inc.

Reason: Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
Published: January 22, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-557-09

by Lupin Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Published: January 22, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.

by B. Braun Medical Inc

Reason: Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
Published: January 22, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA

by Mutual Pharmaceutical Company, Inc.

Reason: Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Published: January 15, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07

by Mutual Pharmaceutical Company, Inc.

Reason: Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Published: January 15, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA

by Mutual Pharmaceutical Company, Inc.

Reason: Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Published: January 15, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.

by Watson Laboratories Inc

Reason: Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Published: January 15, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98

by Teva Pharmaceuticals USA

Reason: Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Published: January 8, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.

by Hospira Inc.

Reason: Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Published: January 8, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).

by Qualitest Pharmaceuticals

Reason: Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Published: January 8, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,

by Sandoz Inc

Reason: Subpotent; Hydrochlorothiazide at the 9 month time point.
Published: January 8, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus¿¿ labels. NDC 0703-5233-13 (carton), NDC 0703-5233-11 (vial) or NDC 0703-5233-93 (carton), NDC 0703-5233-91 (vial)

by Teva Pharmaceuticals USA

Reason: Presence of Precipitate; precipitation of drug product
Published: January 8, 2014
Distribution: Nationwide

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Data last updated: September 30, 2026 ET

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.