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 2769

  • LowFDA (Devices)·Z-2810-2015·2015-09-30

    Stryker Recalls Trident Hip Implant Components Due to Documentation Error

    Stryker Howmedica Osteonics is recalling 16 units of Trident hip implant inserts due to a documentation issue, despite the parts meeting all device specifications.

    Product
    Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2817-2015·2015-09-30

    BD Biosciences Recalls CD4 FITC Reagent Due to Spanish Labeling Error

    Becton, Dickinson and Company is recalling 128 units of CD4 (SK3), FITC reagent because the Spanish text on the label incorrectly identifies the product as CD8 FITC.

    Product
    CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2773-2015·2015-09-23

    Pointe Scientific Creatinine Reagent Recall Due to Labeling Error

    Pointe Scientific is recalling 93 kits of Creatinine Reagent C7539-150 because the R1 and R2 reagent bottles are mislabeled, which prevents valid test results.

    Product
    Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2779-2015·2015-09-23

    Leica ASP200S/ASP300S Tissue Processor Recall for Wiring Defect

    Leica Microsystems is recalling 901 tissue processors due to incorrect internal wiring that may prevent remote alarms from functioning during instrument failure.

    Product
    The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
    Category
    Medical Device
    Distribution
    31 states
  • LowFDA (Devices)·Z-2764-2015·2015-09-23

    Pointe Scientific autoHDL Reagent Recalled Due to Potential Crystals

    Pointe Scientific is recalling autoHDL Reagent H7545 because crystals may be present in the R1 reagent, potentially resulting from freezing during transport.

    Product
    Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits:
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Drugs)·D-1429-2015·2015-09-23

    Akorn Recalls IC-Green Injection Kits Due to Low Potency

    Akorn, Inc. is recalling 370 kits of IC-Green (indocyanine green for injection) because a low out-of-specification potency result was found.

    Product
    IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) pe
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1430-2015·2015-09-23

    Novartis Recalls Dexmethylphenidate HCl Extended-Release Capsules for Dissolution Failure

    Novartis Pharmaceuticals Corp. is recalling 10,767 bottles of Dexmethylphenidate HCl Extended-Release capsules because stability testing showed the product failed to meet dissolution specifications.

    Product
    Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
    Category
    Drug
    Distribution
    0 states
  • 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-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-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-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-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-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 (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-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 (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-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-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-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-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