The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

15701–15725 of 21645

  • ModerateFDA (Drugs)·D-0019-2016·2015-10-21

    QC Quality Choice Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling QC Quality Choice Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result.

    Product
    QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0126-2016·2015-10-21

    Synthes Screw Inserter Recalled for Incorrect Etched Graphics

    Synthes (USA) Products LLC is recalling 793 units of the Screw Inserter because the etched graphics may not correspond to the instrument's actual angle.

    Product
    Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0024-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Variety Packs Due to Potential Mold

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce Variety Packs due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Variety Packs, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Food)·F-0021-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Pumpkin Cinnamon, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Apple Pumpkin Cinnamon, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0016-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Potential Data Loss

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.

    Product
    Toshiba Aquilion CT System TSX-301C
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0030-2016·2015-10-21

    Ohm Recalls Loratadine Tablets Due to Out-of-Specification Assay Results

    Ohm Laboratories is recalling specific batches of Leader Loratadine Orally Disintegrating Tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0018-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Grape, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Apple Grape, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Drugs)·D-0036-2016·2015-10-21

    Ohm Recalls Up&Up Loratadine Tablets for Out-of-Specification Assay

    Ohm Laboratories is recalling Up&Up loratadine tablets because they failed an assay test, potentially making them superpotent.

    Product
    Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0016-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Banana, due to the potential presence of mold. The recall affects 34,573 cases distributed in the US and Canada.

    Product
    GoGo SQueeZ Applesauce, Apple Banana, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0122-2016·2015-10-21

    Alere Cholestech LDX Multianalyte Controls Recalled for Incorrect Ranges

    Alere San Diego is recalling Cholestech LDX Multianalyte Controls because the assigned control ranges for Total Cholesterol and Triglycerides are incorrect.

    Product
    Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0010-2016·2015-10-21

    Shawnee Milling Recalls All Purpose Flour Due to Foreign Material

    Shawnee Milling Company is recalling specific lots of all-purpose flour due to the presence of foreign material. The recall covers products distributed in five states.

    Product
    Sysco 25 pound All Purpose Flour: Best By 07/22/2016; Always Save 5 pound All Purpose Flour: Best By 07/23/2016; Best Choice 5 pound All Purpose Flour: Best By 07/23/2016; Hy Top 5 pound All Purpose Flour: Best By 07/24/2016
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0011-2016·2015-10-21

    Shawnee Milling Company Recalls Self-Rising Flour Due to Foreign Material

    Shawnee Milling Company is recalling multiple brands of self-rising flour because of foreign material. The affected products were distributed in five states.

    Product
    Shawnee Milling Company Hotel And Restaurant Self Rising Climax Four Net 50 Lbs.; Always Save Self-Rising Flour Enriched Bleached Net Wt 5 LB (2.26kg) in waxed paper bag; Best Choice Flour Self-Rising Enriched Bleached Net Wt 5 LB (2.26 kg) in wax paper bag; HyTop Enriched Flour…
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0033-2016·2015-10-21

    Ohm Laboratories Recalls Loratadine Tablets for Out-of-Specification Assay

    Ohm Laboratories is recalling Premier Value Loratadine Orally Disintegrating Tablets because an assay test result was out of specification.

    Product
    Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2016·2015-10-21

    Natus Neurology Recalls NicoletOne Software Due to Signal Obstruction

    Natus Neurology is recalling NicoletOne Software v5.94 because a persistent impedance check signal obscures EEG data, potentially affecting clinical monitoring.

    Product
    NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0029-2016·2015-10-21

    Ohm Recalls HEB Loratadine Tablets Due to Out-of-Specification Assay

    Ohm Laboratories is recalling HEB Loratadine Orally Disintegrating Tablets because an out-of-specification assay result indicated the drug was superpotent.

    Product
    HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0018-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Data Loss Risk

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may cause acquired raw data to not be saved.

    Product
    Toshiba Aquilion CT System TSX-303A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0015-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Mango, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Apple Mango, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Food)·F-0014-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Peach Sweet Potato, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Apple Peach Sweet Potato, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Drugs)·D-0014-2016·2015-10-21

    Actavis Recalls Metformin Hydrochloride Extended-Release Tablets for Dissolution Failure

    Actavis is recalling 13,284 bottles of Metformin Hydrochloride Extended-Release Tablets, 1000 mg, because they failed dissolution specifications at the 8-hour timepoint.

    Product
    Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0014-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Data Loss Risk

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.

    Product
    Toshiba Aquilion CT System TSX-301A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0019-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Organic Apple, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Organic Apple, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Food)·F-0022-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Berry Pear, due to the potential presence of mold. Consumers should check their pantries for affected lots.

    Product
    GoGo SQueeZ Applesauce, Berry Pear, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states