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.

1126–1150 of 2741

  • LowFDA (Drugs)·D-0426-2018·2018-02-07

    Fresenius Kabi Recalls Vecuronium Bromide Vials Due to Impurity Failure

    Fresenius Kabi USA is recalling 35,620 vials of Vecuronium bromide for Injection due to an out-of-specification result for a related compound.

    Product
    Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0418-2018·2018-02-07

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities

    Dr. Reddy's Laboratories is recalling Atorvastatin Calcium 10 mg tablets because stability testing showed out-of-specification results for total degradation impurities.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0420-2018·2018-02-07

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures

    Dr. Reddy's is recalling 12,579 bottles of Atorvastatin Calcium 40 mg tablets because they failed impurity specifications during stability testing.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0419-2018·2018-02-07

    Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures

    Dr. Reddy's Laboratories is recalling Atorvastatin Calcium 20 mg tablets because stability testing revealed out-of-specification total degradation impurities.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0230-2018·2018-01-31

    Mylan Recalls Bupropion HCL Extended-Release Tablets Due to Impurities

    Mylan Pharmaceuticals is voluntarily recalling specific bottles of bupropion HCL extended-release tablets due to out-of-specification impurities found during routine stability testing.

    Product
    bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0408-2018·2018-01-31

    Smith & Nephew Recalls EVOS Flex Plates Due to Packaging Error

    Smith & Nephew is recalling 12 units of EVOS 2.4MM Flex Plates because the packaging contained templates. The recall covers distribution to Oregon and Colombia.

    Product
    smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0398-2018·2018-01-31

    Anspach Effort Recalls Oscillating Saw Attachment Due to Shipping Error

    The Anspach Effort, Inc. is voluntarily recalling one oscillating saw attachment because it was mistakenly shipped to a non-veterinary customer.

    Product
    OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0340-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling 16 units of Tryptik 2 C-Plate Self Tapping screws distributed in California because the product labeling contains an incorrect sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0339-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screw Due to Labeling Error

    Spineart SA is recalling 9 units of Tryptik 2 C-Plate Self-Tapping Screws because the product labeling displays a sketch of a self-drilling screw instead of the correct self-tapping screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0342-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling 8 units of Tryptik 2 C-Plate Self Tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0336-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling 54 units of Tryptik 2 C-Plate self-tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0219-2018·2018-01-24

    Shionogi Recalls Mefenamic Acid Capsules Due to Foreign Particles

    Shionogi Inc. is recalling 968 bottles of Mefenamic Acid Capsules, 250 mg, due to the presence of black particles found during routine stability testing.

    Product
    Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·003-2018·2018-01-18

    Duke Sandwich Productions Recalls Chicken Salad Due to Misbranding

    Duke Sandwich Productions is recalling approximately 743 pounds of chicken salad products because they were packaged in pimento cheese containers with mismatched labels.

    Product
    DiscoverFresh Foods — Duke Sandwich Productions, Inc. Recalls Ready-To-Eat Chicken Salad Products Due to Misbranding
    Category
    Food
    Distribution
    6 states
  • LowFDA (Drugs)·D-0211-2018·2018-01-17

    Akorn Recalls Gabapentin Oral Solution Due to Unapproved Manufacturer

    Akorn Inc is recalling 4,885 bottles of Gabapentin Oral Solution because the product was released with an unapproved active ingredient manufacturer.

    Product
    Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0153-2018·2018-01-17

    Enoxaparin Sodium Injection Recalled for Labeling Error on Declared Strength

    Sanofi-Aventis is recalling Enoxaparin Sodium injections because a single syringe with a different strength was found in a carton labeled 120 mg/0.8 mL.

    Product
    ENOXAPARIN SODIUM — ENOXAPARIN SODIUM (ENOXAPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0312-2018·2018-01-10

    Zimmer Biomet Recalls PPS RingLoc+ Acetabular Shells Due to Missing Etching

    Zimmer Biomet is recalling 15 units of PPS RingLoc+ Acetabular Shells because the product was distributed with missing etching.

    Product
    PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc¿+…
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-0308-2018·2018-01-10

    Beckman Coulter Access 2 Immunoassay System Recalled for Burn Risk

    Beckman Coulter is recalling Access 2 Immunoassay Systems due to a potential for minor skin burns if the tool contacts the reagent storage interface board during pipettor alignment.

    Product
    Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0310-2018·2018-01-10

    Beckman Coulter Recalls UniCel DxC 600i Systems Due to Burn Risk

    Beckman Coulter is recalling two UniCel DxC 600i SYNCHRON Access Clinical Systems because a tool may contact a board and cause minor skin burns during alignment.

    Product
    UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0309-2018·2018-01-10

    Beckman Coulter Access 2 Immunoassay System Recalled for Burn Risk

    Beckman Coulter is recalling three Access 2 Immunoassay Systems due to a potential risk of minor skin burns during pipettor alignment.

    Product
    Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0130-2018·2018-01-03

    Pharmedium Recalls Morphine Sulfate Injection Due to Labeling Errors

    Pharmedium Services LLC is recalling morphine sulfate injection due to incorrect or missing lot and expiration dates on the labels.

    Product
    morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0132-2018·2018-01-03

    Pharmedium Recalls Hydromorphone Injection Due to Labeling Errors

    Pharmedium Services LLC is recalling Hydromorphone HCl Injection due to incorrect or missing lot and expiration dates.

    Product
    HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0131-2018·2018-01-03

    Pharmedium Recalls Morphine Sulfate Injection Due to Labeling Errors

    Pharmedium Services LLC is recalling specific lots of compounded morphine sulfate injection because the labels may have incorrect or missing lot and expiration dates.

    Product
    morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0133-2018·2018-01-03

    Auryxia Ferric Citrate Tablets Recalled for Damaged Desiccant Packets

    Keryx Biopharmaceuticals is recalling Auryxia (ferric citrate) tablets because damaged silica gel packets may allow desiccant granules to contact the medication.

    Product
    AURYXIA — AURYXIA (FERRIC CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0522-2018·2017-12-27

    New Century Snacks Recalls Mixed Nuts Due to Incorrect Back Panel Labeling

    New Century Snacks LLC is recalling Happy Belly Deluxe Mixed Nuts because the back panel ingredients and nutrition facts were incorrect. The principal display label correctly lists the main allergens.

    Product
    Happy Belly Deluxe Mixed Nuts - roasted and salted with sea salt. Cashews, Almonds, Brazil nuts, pecans & Hazelnuts 16 oz. (454 g); Allergen information: contains Milk, Almonds, Wheat, Peanuts. UPC 48719 09577 Cranberry & Nuts Trail mix has dried cranberries, cashew &…
    Category
    Food
    Distribution
    10 states