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.

501–525 of 2766

  • LowFDA (Drugs)·D-1314-2020·2020-06-24

    Aurobindo Pharma Recalls Olanzapine Tablets Due to Impurity Failures

    Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 2.5 mg, because the product failed impurities and degradation specifications.

    Product
    Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowNHTSA·20V372000·2020-06-24

    Volkswagen Recalls Two 2018 Golf GTI Vehicles for VIN Label Mismatch

    Volkswagen is recalling two 2018 Golf GTI vehicles because the VIN on the Federal Certification label may not match the actual vehicle VIN, potentially preventing owners from identifying safety recalls.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2370-2020·2020-06-24

    Abbott Vascular Recalls Xience Sierra Stents Due to Incorrect Expiration Date

    Abbott Vascular is recalling 13 units of Xience Sierra coronary stents because they bear an incorrect expiration date.

    Product
    Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g; Lot number 903224A,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1315-2020·2020-06-24

    Aurobindo Recalls Olanzapine Tablets Due to Failed Impurity Specifications

    Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 7.5 mg, because the product failed impurity and degradation specifications.

    Product
    Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1340-2020·2020-06-17

    Akorn Recalls Prednisolone Sodium Phosphate Oral Solution Due to Discoloration

    Akorn, Inc. is recalling specific lots of Prednisolone Sodium Phosphate Oral Solution because the product failed a color test.

    Product
    Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1281-2020·2020-06-03

    Lamotrigine Tablets Recalled for Presence of Foreign Silica Granules

    Jubilant Cadista Pharmaceuticals is recalling Lamotrigine Tablets, 150 mg, due to the presence of foreign silica granules consistent with desiccant pack material.

    Product
    Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-2121-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error

    Boston Scientific is voluntarily removing specific spinal cord stimulation leads because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inh
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2119-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error

    Boston Scientific is voluntarily removing specific spinal cord stimulation leads because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1) M
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2123-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Adapters Due to Labeling Error

    Boston Scientific is voluntarily removing two Precision M8 Adapters because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilater
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2120-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Extension Kits Due to Labeling Error

    Boston Scientific is voluntarily removing 19 units of 35 cm 8 Contact Extension Kits because the 'use by date' on the label is later than the correct date.

    Product
    Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Product Usage: Contact
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2125-2020·2020-06-03

    Boston Scientific Recalls Deep Brain Stimulation Lead Extensions Due to Labeling Error

    Boston Scientific is voluntarily removing specific Deep Brain Stimulation lead extensions because the 'use by date' on the label is later than the correct date.

    Product
    Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2122-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error

    Boston Scientific is voluntarily removing certain spinal cord stimulation leads and extensions because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. Package Contents Percutaneous Permanent Lead Kits (
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1272-2020·2020-05-27

    InvaGen Recalls Gabapentin Tablets Due to Impurity Test Failure

    InvaGen Pharmaceuticals is recalling 2,202 bottles of Gabapentin 600 mg tablets because they failed an impurity test during stability testing.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2038-2020·2020-05-27

    Pega Medical Recalls SLIM System Handle Due to Lot Number Mismatch

    Pega Medical Inc. is recalling three units of the SLIM System handle because the lot number on the instrument does not match the packaging label.

    Product
    Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2041-2020·2020-05-27

    ImmersiveView software version 2.1 recalled for internal repetitive glitch

    Immersivetouch Inc is recalling two units of ImmersiveView software version 2.1 due to an observed internal repetitive software glitch.

    Product
    ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-1266-2020·2020-05-20

    ChapStick Lip Balm Recalled for Packaging Separation

    Glaxosmithkline is recalling 288 packages of ChapStick Total Hydration Moisture Tint Peachy Keen due to observed separation in the secondary packaging.

    Product
    CHAPSTICK TOTAL HYDRATION MOISTURE TINT PEACHY KEEN — CHAPSTICK TOTAL HYDRATION MOISTURE TINT PEACHY KEEN (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1268-2020·2020-05-20

    ChapStick Total Hydration Moisture Tint Recalled for Packaging Separation

    Glaxosmithkline is recalling ChapStick Total Hydration Moisture Tint Pretty in Pink due to observed separation in the secondary packaging.

    Product
    CHAPSTICK TOTAL HYDRATION MOISTURE TINT PRETTY IN PINK — CHAPSTICK TOTAL HYDRATION MOISTURE TINT PRETTY IN PINK (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1267-2020·2020-05-20

    ChapStick Total Hydration Moisture Tint Recalled for Packaging Separation

    Glaxosmithkline is recalling ChapStick Total Hydration Moisture Tint Very Berry due to observed separation in the secondary packaging.

    Product
    CHAPSTICK TOTAL HYDRATION MOISTURE TINT VERY BERRY — CHAPSTICK TOTAL HYDRATION MOISTURE TINT VERY BERRY (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1849-2020·2020-05-13

    Epimed RF Injector Cannula Recalled for Incorrect Expiration Date

    Epimed International is recalling 1,374 units of RF Injector Cannulas due to incorrect expiration dates on the packaging.

    Product
    R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1908-2020·2020-05-13

    Gentell Honey Hydrogel Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 22,439 units of Gentell Honey Hydrogel 4"x4" Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1907-2020·2020-05-13

    Gentell Honey Hydrogel Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 85,586 units of Gentell Honey Hydrogel 2"x2" Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1895-2020·2020-05-13

    Abbott Recalls C Peptide Calibrator Due to Mexico License Documentation Error

    Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Calibrator in Mexico due to an error in the license renewal documentation process.

    Product
    ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1909-2020·2020-05-13

    Gentell Honey Hydrogel Saturated Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 4,348 units of Gentell Honey Hydrogel Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers,
    Category
    Medical Device
    Distribution
    Distributed nationwide