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.

1301–1325 of 2769

  • LowFDA (Drugs)·D-0701-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 10 mg, because they failed impurity specifications. The recall covers 38,316 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuti
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0703-2017·2017-05-17

    Teva Recalls Prednisolone Oral Solution for Failed Stability Specifications

    Teva Pharmaceuticals USA is recalling specific lots of Prednisolone Oral Solution because they failed stability specifications.

    Product
    PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0695-2017·2017-05-10

    Fagron Recalls Zinc Oxide Paste Due to Labeling Error

    Fagron, Inc. is recalling Zinc Oxide Paste 25% because of an incorrect strength value in the Drug Facts Panel.

    Product
    Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2028-2017·2017-05-10

    Anspach Effort J-Latch Recall for Missing Service Interval Instructions

    The Anspach Effort, Inc. is recalling 16 Small Attachment, J-Latch units because the supplied directions for use did not contain a recommended service interval.

    Product
    SMALL ATTACHMENT, J-LATCH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1941-2017·2017-05-10

    Anspach Effort Recalls BLACKMAX-NEURO Pneumatic System for Missing Service Interval

    The Anspach Effort, Inc. is recalling 25 BLACKMAX-NEURO LOW PRESSURE pneumatic systems because the supplied directions for use did not include a recommended service interval.

    Product
    BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1951-2017·2017-05-10

    Anspach Effort Recalls eMax2 Hybrid Hand Control for Missing Service Interval

    The Anspach Effort, Inc. is recalling 293 eMax2 Hybrid Hand Controls because the supplied directions for use did not contain a recommended service interval.

    Product
    eMax2 Hybrid Hand Control Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0692-2017·2017-05-10

    Aripiprazole Tablets Recalled for Out-of-Specification Assay Results

    The Harvard Drug Group is recalling Aripiprazole Tablets, 2 mg, due to out-of-specification assay results. The recall covers 36,990 tablets distributed nationwide and in Puerto Rico.

    Product
    Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1936-2017·2017-05-10

    Anspach Effort AL-III-DISS Adapter Recall for Missing Service Interval

    The Anspach Effort, Inc. is recalling five AL-III-DISS Adapters because the supplied directions for use did not contain a recommended service interval.

    Product
    AL-III-DISS Adapter Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1892-2017·2017-05-10

    Zimmer TM Ardis Interbody System Recalled for Procedural Error in Literature Approval

    Zimmer Trabecular Metal Technology, Inc. is recalling the TM Ardis Interbody System due to a procedural error in the approval of literature, resulting in the unauthorized release of certain content.

    Product
    The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The sup
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1949-2017·2017-05-10

    Anspach Effort Recalls Electronic Foot Controls Due to Missing Service Interval

    The Anspach Effort, Inc. is recalling 821 Electronic Foot Controls because the supplied directions for use did not contain a recommended service interval.

    Product
    Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1956-2017·2017-05-10

    Anspach Effort Recalls System Consoles for Missing Service Interval Instructions

    The Anspach Effort, Inc. is recalling 462 System Console units because the supplied directions for use did not contain a recommended service interval.

    Product
    System Console, Single Port, with irrigation Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0680-2017·2017-05-03

    McKesson Recalls Donepezil HCl Tablets Due to Out-of-Specification Assay

    McKesson Packaging Services is recalling 476 cartons of Donepezil HCl 10mg tablets because routine stability testing revealed an out-of-specification assay result.

    Product
    Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Devices)·Z-1876-2017·2017-05-03

    Becton Dickinson Recalls Trypticase Soy Agar and Chocolate Agar I-Plates

    Becton Dickinson is recalling one lot of Trypticase Soy Agar and Chocolate Agar I-Plates because they may fail to recover specific Haemophilus organisms.

    Product
    BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX)  I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemoly
    Category
    Medical Device
    Distribution
    Distributed nationwide