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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10801–10825 of 17785

  • SevereFDA (Drugs)·D-0614-2017·2017-04-05

    Claris Fluconazole Injection Recalled for Potential Sterility Breach

    Claris Lifesciences is recalling Fluconazole Injection due to a potential leak that could compromise sterility and contaminate the product.

    Product
    Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0619-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0620-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling specific lots of Atorvastatin Calcium 40 mg tablets due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2017·2017-04-05

    Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed dissolution specifications and long-term stability testing.

    Product
    Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0624-2017·2017-04-05

    Sensodyne Toothpaste Recalled for Foreign Substance and Off-Flavor Complaints

    GSK Consumer Healthcare is recalling Sensodyne Repair & Protect Whitening toothpaste due to the presence of a foreign substance and low concentration of patchouli oil, causing off-flavor and scent complaints.

    Product
    SENSODYNE — SENSODYNE (STANNOUS FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0623-2017·2017-04-05

    Hetero USA Recalls Montelukast Sodium Tablets Due to Discoloration

    Hetero USA Inc. is recalling 65,664 bottles of Montelukast sodium tablets due to a complaint of blue spots and powder inside a sealed bottle.

    Product
    MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0606-2017·2017-03-29

    Legacy Pharmaceutical Recalls Atenolol Tablets Due to Foreign Tablet Presence

    Legacy Pharmaceutical Packaging LLC is recalling 48,012 bottles of atenolol 50 mg tablets because a customer reported finding a paroxetine 20 mg tablet inside a bottle.

    Product
    ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH 45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045; NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0612-2017·2017-03-29

    Fougera Recalls Desonide Ointment Tubes Due to Labeling Mixup

    Fougera Pharmaceuticals is recalling 14,665 tubes of Desonide Ointment because unit boxes may contain tubes labeled as Ketoconazole Cream.

    Product
    Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0610-2017·2017-03-29

    AvKARE Recalls Famciclovir Tablets Due to Impurity Levels

    AvKARE Inc. is recalling 116 cartons of 500 mg Famciclovir tablets because the product exceeded specifications for unknown impurities.

    Product
    Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0604-2017·2017-03-29

    Bayer Recalls A+D Diaper Rash Cream Due to Labeling Error

    Bayer HealthCare Pharmaceuticals is recalling A+D Diaper Rash Cream due to a labeling claim issue regarding undeclared excipients.

    Product
    A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0609-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling specific lots of Quillivant XR extended-release oral suspension because the product failed to meet dissolution specifications at 12 months.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0608-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling Quillivant XR extended-release oral suspension due to failed dissolution specifications at 12 months.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0607-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling Quillivant XR extended-release oral suspension because it failed to meet dissolution specifications at 12 months. The recall affects 28,938 units distributed nationwide.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0528-2017·2017-03-22

    Synergy Rx Recalls Minoxidil Products Due to Sterility Assurance Concerns

    Synergy Rx is recalling Minoxidil and Minoxidil/Retinoic Acid products nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0602-2017·2017-03-22

    Synergy Rx Recalls Kojic Acid and Azelaic Acid Cream Due to Sterility Concerns

    Synergy Rx is recalling Kojic Acid 8%/Azelaic Acid 15% Cream because it lacks assurance of sterility and has CGMP deviations.

    Product
    KOJIC ACID 8%/AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0574-2017·2017-03-22

    Synergy Rx Recalls Tri-Bleaching Cream Due to Sterility Assurance Issues

    Synergy Rx is recalling Tri-Bleaching Cream because it lacks assurance of sterility and has CGMP deviations.

    Product
    TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0533-2017·2017-03-22

    Synergy Rx Bleaching Cream Recalled for Sterility Assurance Issues

    Synergy Rx is recalling Bleaching Cream products due to a lack of assurance of sterility and CGMP deviations.

    Product
    BLEACHING CREAM 0.1% CREAM, BLEACHING CREAM HQ4%, BLEACHING CREAM-NO HQ, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0593-2017·2017-03-22

    Synergy Rx Recalls Lidocaine Creams Due to Sterility Assurance Issues

    Synergy Rx is recalling various lidocaine cream and ointment products nationwide due to a lack of assurance of sterility and CGMP deviations.

    Product
    LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% CREAM, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% OINTMENT LIDOCAINE 23%/ TETRACAINE 7% CREAM, LIDOCAINE 23%/TETRACAINE 7% OINTMENT, LIDOCAINE…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0594-2017·2017-03-22

    Synergy Rx Recalls Azelaic Acid 15% Cream Due to Sterility Concerns

    Synergy Rx is recalling Azelaic Acid 15% Cream because the product lacks assurance of sterility and has CGMP deviations.

    Product
    AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0552-2017·2017-03-22

    Synergy Rx Recalls Calming Cream Due to Sterility Assurance Concerns

    Synergy Rx is recalling Calming Cream (Hydrocortisone 2.5%) because the product lacks assurance of sterility and has CGMP deviations.

    Product
    CALMING CREAM (Hydrocortisone 2.5%, Aloe vera powder), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0555-2017·2017-03-22

    Synergy Rx Recalls CLEAR 2 Due to Sterility Assurance Concerns

    Synergy Rx is recalling all lots of CLEAR 2 (Benzoyl Peroxide 2.5%, Clindamycin 1.2%) because the product lacks assurance of sterility and has CGMP deviations.

    Product
    CLEAR 2 (Benzoyl Peroxide 2.5%, Clindamycin 1.2% ), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0581-2017·2017-03-22

    Synergy Rx Recalls Betamethasone 0.25% Due to Sterility Assurance Issues

    Synergy Rx is recalling Betamethasone 0.25% cream because it may not be sterile. The recall covers all lots distributed nationwide.

    Product
    BETAMETHASONE 0.25%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0536-2017·2017-03-22

    Synergy Rx Recalls Erythromycin Cream Due to Sterility Assurance Issues

    Synergy Rx is recalling Erythromycin 2% in CeraVe Cream and Erythromycin 3% / Retinoic Acid 0.05% due to lack of assurance of sterility and CGMP deviations.

    Product
    ERYTHROMYCIN 2% IN CERAVE CREAM, ERYTHROMYCIN 3% / RETINOIC ACID 0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide