The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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16201–16225 of 18042

  • ModerateFDA (Drugs)·D-621-2014·2014-01-22

    FDA Recalls Tizanidine Tablets Due to Potential Labeling Mixup

    Aidapak Services is recalling Tizanidine HCl tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    tiZANidine HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-601-2014·2014-01-22

    Etodolac Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Etodolac 400 mg tablets due to a potential label mixup with Pancrelipase DR capsules.

    Product
    ETODOLAC Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672401801
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-585-2014·2014-01-22

    Aidapak Recalls Aspirin EC Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Aspirin EC DR tablets because they may be mislabeled as Melatonin or Docusate Sodium.

    Product
    ASPIRIN EC DR Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348098015
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-599-2014·2014-01-22

    Aidapak Recalls Pyridoxine HCL Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Pyridoxine HCL 50 mg tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    PYRIDOXINE HCL Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51645090901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-553-2014·2014-01-22

    Aidapak Recalls Omega-3 Fatty Acid Capsules Due to Labeling Error

    Aidapak Services, LLC is recalling Omega-3 Fatty Acid Capsules, 1000 mg, because they may be mislabeled as other medications. The affected products were distributed in Arizona, California, Oregon, and Washington.

    Product
    OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022921
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-535-2014·2014-01-22

    Aidapak Recalls Multivitamin Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling specific lots of multivitamin capsules that may be mislabeled as caffeine or melatonin tablets.

    Product
    MULTIVITAMIN/ MULTIMINERAL/ LUTEIN Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24208063210
    Category
    Drug
    Distribution
    4 states
  • LowFDA (Drugs)·D-742-2014·2014-01-22

    Novartis Recalls Theraflu Warming Relief Due to Unknown Degradant

    Novartis Consumer Health is recalling Theraflu Warming Relief caplets because an unknown degradant was found during stability testing.

    Product
    Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-741-2014·2014-01-22

    Novartis Recalls Maximum Strength Comtrex Due to Unknown Degradant

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Severe Cold & Sinus because an unknown degradant was found during stability testing.

    Product
    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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-740-2014·2014-01-22

    Novartis Recalls Maximum Strength Comtrex Day/Night Flu Therapy

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Day/Night Flu Therapy due to an unknown degradant found during stability testing.

    Product
    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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-739-2014·2014-01-22

    Novartis Recalls Comtrex Nighttime Cold and Cough Due to Unknown Degradant

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Nighttime Cold & Cough because an unknown degradant was found during stability testing.

    Product
    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.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-743-2014·2014-01-22

    Novartis Recalls Theraflu Nighttime Warming Relief Due to Unknown Degradant

    Novartis Consumer Health is recalling Theraflu Nighttime Warming Relief caplets because an unknown degradant was found during stability testing.

    Product
    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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-738-2014·2014-01-22

    Novartis Recalls Comtrex Cold and Cough Caplets Due to Unknown Degradant

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Day/Night Cold & Cough caplets because an unknown degradant was found during stability testing.

    Product
    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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-401-2014·2014-01-15

    Triple Mix Injectable Recalled for Lack of Sterility Assurance

    The Compounding Center at Blue Ridge is recalling 92 units of Triple Mix Injectable due to quality control concerns identified during an FDA inspection.

    Product
    Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-402-2014·2014-01-15

    FDA Recalls PGE Injectable Due to Sterility Assurance Concerns

    The Compounding Center at Blue Ridge is recalling PGE 20 mcg/mL and 40 mcg/mL injectables due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-397-2014·2014-01-15

    Watson Recalls Carisoprodol Tablets Due to Metal Particulates

    Watson Laboratories is recalling 4,439 bottles of Carisoprodol Tablets because metal particulates were visually observed in the tablets.

    Product
    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-403-2014·2014-01-15

    FDA Recalls Super Triple Mix Injectable Due to Sterility Concerns

    The FDA is recalling all lots of Super Triple Mix Injectable from The Compounding Center at Blue Ridge due to quality control concerns regarding sterility assurance.

    Product
    Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-405-2014·2014-01-15

    FDA Recalls Papaverine/Phentolamine Injections Due to Sterility Concerns

    The Compounding Center at Blue Ridge is recalling all lots of Papaverine/Phentolamine injections due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-404-2014·2014-01-15

    Quad Mix Injectable Recalled Due to Sterility Concerns

    The Compounding Center at Blue Ridge is recalling all lots of Quad Mix Injectable due to quality control concerns identified during an FDA inspection.

    Product
    Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-398-2014·2014-01-15

    Mutual Pharmaceutical Recalls FIBRICOR Tablets Due to Labeling Error

    Mutual Pharmaceutical is recalling FIBRICOR (fenofibric acid) tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-399-2014·2014-01-15

    Mutual Pharmaceutical Recalls Fenofibric Acid Tablets Due to Labeling Error

    Mutual Pharmaceutical is recalling specific lots of Fenofibric Acid tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.

    Product
    Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-400-2014·2014-01-15

    Mutual Pharmaceutical Recalls Fenofibric Acid Tablets Due to Labeling Error

    Mutual Pharmaceutical is recalling specific lots of Fenofibric Acid tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-395-2014·2014-01-08

    Hospira Recalls Bupivacaine Hydrochloride Vials Due to Sterility Concerns

    Hospira Inc. is recalling 65,109 vials of Bupivacaine Hydrochloride with Epinephrine due to a potential breach in the aseptic process caused by equipment failure.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-392-2014·2014-01-08

    Teva Recalls Daunorubicin Hydrochloride Injection Due to Precipitate Presence

    Teva Pharmaceuticals USA is recalling specific lots of Daunorubicin Hydrochloride Injection because the drug product contains precipitate.

    Product
    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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-396-2014·2014-01-08

    Teva Recalls Niacin Extended Release Tablets Due to Broken Tablets

    Teva Pharmaceuticals is recalling Niacin Extended Release Tablets, 500 mg, because the tablets may be broken.

    Product
    Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-393-2014·2014-01-08

    Sandoz Recalls Subpotent Fosinopril Sodium and Hydrochlorothiazide Tablets

    Sandoz Inc. is recalling specific lots of Fosinopril Sodium and Hydrochlorothiazide tablets because the hydrochlorothiazide content was subpotent at the 9-month time point.

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