The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

1876–1900 of 2741

  • LowNHTSA·15V579000·2015-09-21

    Mitsubishi Recalls 2011 Outlander Sport for Incorrect Certification Labels

    Mitsubishi is recalling 2011 Outlander Sport vehicles manufactured on December 3, 2010, due to incorrect certification labels lacking the correct VIN. Dealers will install corrected labels free of charge.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1421-2015·2015-09-16

    Mutual Pharmaceutical Recalls Felodipine Tablets Due to Chemical Contamination

    Mutual Pharmaceutical is recalling specific lots of Felodipine Extended-Release Tablets because benzophenone leached from the product label varnish.

    Product
    Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1422-2015·2015-09-16

    Mutual Pharmaceutical Recalls Felodipine Tablets Due to Chemical Contamination

    Mutual Pharmaceutical is recalling specific lots of Felodipine Extended-Release Tablets because benzophenone leached from the label varnish.

    Product
    Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1424-2015·2015-09-16

    Mutual Pharmaceutical Recalls Imipramine HCl Tablets Due to Chemical Contamination

    Mutual Pharmaceutical is recalling specific lots of Imipramine HCl tablets because benzophenone leached from the label varnish.

    Product
    Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1419-2015·2015-09-16

    CVS Sugar Free Black Cherry Cough Drops Recalled for Foreign Tablets

    Bestco, Inc. is recalling CVS Sugar Free Black Cherry Cough Drops because they may contain comingled Sugar Free Honey Lemon cough drops.

    Product
    CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25 Drop Bags (UPC: 050428 448526) and b) 36 drop bags (UPC: 050428 476581), Over the Counter. Distributed by: CVS Pharmacy, Inc., One CVS Drive Woonsocket, RI 02895.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1426-2015·2015-09-16

    FDA Recalls Methocarbamol Tablets Due to Presence of Hair

    Golden State Medical Supply Inc. is recalling 1,165 bottles of Methocarbamol 500 mg tablets because they contain hair.

    Product
    METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged by GSMS Incorporated, Camarillo, CA 93012, USA, NDC: 60429-118-05.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1418-2015·2015-09-16

    Oasis Medical Recalls ImproVue Ophthalmic Drops for pH Specification Failure

    Oasis Medical is recalling 909 cartons of ImproVue Ophthalmic Lubricant Drops due to a failure to meet pH specifications. The affected lot was distributed in Florida.

    Product
    ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1416-2015·2015-09-09

    Silarx Lamivudine Oral Solution Recalled for Mismatched Expiration Dates

    Silarx Pharmaceuticals is recalling 576 bottles of Lamivudine Oral Solution because the expiration date on the carton does not match the bottle label.

    Product
    Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2478-2015·2015-09-09

    Abbott FIRMap 60mm Catheter Recalled for Incorrect Expiration Date Labeling

    Abbott Electrophysiology is recalling 86 units of FIRMap 60mm Catheters because the expiration date was incorrectly printed on the labels.

    Product
    FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to…
    Category
    Medical Device
    Distribution
    19 states
  • LowFDA (Drugs)·D-1370-2015·2015-09-02

    Taro Recalls Topicort Topical Spray Due to Impurity Test Failures

    Taro Pharmaceuticals is recalling Topicort topical spray because impurity testing failed at 6 and 9 months. The recall covers 16,320 bottles distributed nationwide.

    Product
    TOPICORT — TOPICORT (DESOXIMETASONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1376-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is recalling specific lots of Amlodipine Besylate and Atorvastatin Calcium tablets because they contain subpotent atorvastatin.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1374-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is recalling 576 bottles of Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component is subpotent.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1375-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is recalling 984 bottles of Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component is subpotent.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1379-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's is recalling Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component was found to be subpotent.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1371-2015·2015-09-02

    KVK-Tech Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    KVK-Tech is recalling specific lots of Phentermine Hydrochloride Capsules because they failed impurity specifications during stability testing.

    Product
    Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1378-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's is recalling specific lots of Amlodipine Besylate and Atorvastatin Calcium tablets because they contain subpotent atorvastatin.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·118-2015·2015-08-31

    Holten Meat Recalls Beef Patties Due to Unlabeled MSG

    Holten Meat Inc. is recalling approximately 501,509 pounds of Extra Value Meats Quarter Pound Beef Patties because monosodium glutamate (MSG) was used but not listed on the label.

    Product
    Branding Iron Holdings - Holten Meat — Recall Notification Report 118-2015 (Beef Patties)
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2432-2015·2015-08-26

    Cepheid Recalls Xpert CT/NG Urine Specimen Collection Kits

    Cepheid is recalling Xpert CT/NG Urine Specimen Collection Kits because some lots contain a sub-component with an expiration date earlier than the kit's expiration date.

    Product
    Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1350-2015·2015-08-26

    Qualitest Recalls Ampicillin Capsules Due to Unapproved Labeling

    Vintage Pharmaceuticals LLC is recalling 360 bottles of Ampicillin Capsules, USP, 250 mg, because they are labeled with unapproved labeling.

    Product
    AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-2419-2015·2015-08-26

    Getinge 86 Series Washer/Disinfector Recalled for Remote Access Vulnerability

    Getinge Disinfection AB is recalling 20 Model 8666 and 8668 washer/disinfectors due to a potential for unauthenticated remote network access.

    Product
    Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
    Category
    Medical Device
    Distribution
    12 states
  • LowFDA (Devices)·Z-2431-2015·2015-08-26

    Cepheid Recalls Xpert CT/NG Vaginal and Endocervical Specimen Collection Kits

    Cepheid is recalling Xpert CT/NG Vaginal/Endocervical Specimen Collection Kits because some lots contain a sub-component with an earlier expiration date than the kit itself.

    Product
    Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2434-2015·2015-08-26

    BD Vacutainer SST Plus Blood Collection Tubes Recalled for Stopper Defects

    Becton Dickinson & Company is recalling specific lots of BD Vacutainer SST Plus Blood Collection Tubes because some stoppers were manufactured with a reduced cycle cure time.

    Product
    BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of collecting, transporting, separating, and processing blood in a closed tube.
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Drugs)·D-1345-2015·2015-08-26

    Sun Pharma Recalls Bupropion Hydrochloride Tablets for Dissolution Failure

    Sun Pharma Global Fze is recalling 35,235 bottles of Bupropion Hydrochloride Extended-Release Tablets because they failed to meet drug release specifications during stability testing.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2951-2015·2015-08-19

    Mason Vitamins Recalls Mislabeled Coenzyme Q-10 50 mg Softgels

    Mason Vitamins, Inc. is recalling 13,027 bottles of Coenzyme Q-10 50 mg softgels because some bottles were mislabeled with the wrong dosage.

    Product
    Coenzyme Q-10 50 mg label reads in part, "***Major***CO Q-10 50 MG***For healthy HEART & IMMUNE function***Promotes ENERGY in all Body Cells***Dietary Supplement 30 SOFTGELS***."
    Category
    Food
    Distribution
    31 states