The Recall Desk

Hazard

Unapproved Material recalls

7 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2022-10-26

Of the 7 unapproved material recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unapproved material recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–7 of 7

  • HighFDA (Devices)·Z-0111-2023·2022-10-26

    Medicina Oral Tip Syringe recalled for unapproved plunger material

    Medicina Uk Ltd is recalling Medicina Oral Tip Syringe 2.5ml nationwide because the plunger component was manufactured with polyethylene instead of the approved polypropylene material.

    Product
    Medicina Oral Tip Syringe 2.5ml Code: OT25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0676-2018·2018-02-28

    Hologic Recalls Rapid for TLiIQ System Kits Due to Unapproved Material

    Hologic is recalling 165 Rapid for the TLiIQ System kits because they were manufactured with a new material before FDA approval.

    Product
    Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0677-2018·2018-02-28

    Hologic Rapid for TLiIQ System Cassettes Recalled for Unapproved Material

    Hologic is recalling Rapid for the TLiIQ System cassettes because they were manufactured with material from a new supplier before FDA approval of the change.

    Product
    Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1095-2014·2014-03-12

    Teva Recalls Hydroxyzine Pamoate Capsules Due to Unapproved Manufacturing Material

    Teva Pharmaceuticals is recalling specific lots of Hydroxyzine Pamoate capsules because they were manufactured using an unapproved active pharmaceutical ingredient.

    Product
    HYDROXYZINE PAMOATE — HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1131-2014·2014-03-12

    AlterG Anti-Gravity Treadmill Accessory Shorts Recalled for Unapproved Material

    AlterG, Incorporated is recalling 2,221 accessory shorts for the AlterG Anti-Gravity Treadmill because unapproved material caused them to stretch unusually, making them uncomfortable for patients.

    Product
    Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1094-2014·2014-03-12

    Teva Recalls Dextroamphetamine Tablets Due to CGMP Deviations

    Teva Pharmaceuticals is recalling specific lots of Dextroamphetamine tablets because they were manufactured using unapproved material and not properly quarantined.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide