The Recall Desk

Hazard

Unapproved Marketing recalls

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

What the numbers show

Total
5
Critical
2
Severe
0
Most recent
2026-02-11

Of the 5 unapproved marketing recalls we have scored against our rubric, 2 (40%) 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 marketing 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.

1–5 of 5

  • CriticalFDA (Drugs)·D-0304-2026·2026-02-11

    Male supplement capsules recalled after FDA analysis found tadalafil

    Green Lumber Holdings is recalling Green Lumber Natural Fuel For Men capsules because FDA analysis found the product to contain tadalafil, and it is marketed without an approved application.

    Product
    Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0063-2024·2023-11-01

    Pregnancy test strips recalled for lack of FDA authorization and quality documentation

    Universal Meditech Inc. recalled DiagnosUS hCG pregnancy test strips because the company distributed them without FDA marketing authorization and cannot provide manufacturing compliance documentation. The firm is ceasing operations.

    Product
    DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
    Category
    Medical Device
    Distribution
    8 states
  • CriticalFDA (Drugs)·D-0033-2021·2020-10-07

    Volu-Sol Handrub Sanitizing Solution Recalled for Unapproved Marketing

    Volu-Sol, Inc. is recalling handrub sanitizing solution marketed without an approved NDA/ANDA and listing methanol as an inactive ingredient.

    Product
    Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/ 16 fl oz bottle, Vou-Sol 5095 W 2100 S, Salt Lake City, UT 84120, NDC 74401-800-16
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2645-2014·2014-09-24

    FDA Recalls Ultraslim Devices for Marketing Without Clearance

    Advanced Photonic Systems is recalling 235 Ultraslim devices because they were marketed without FDA clearance or approval.

    Product
    Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims th
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Drugs)·D-1056-2014·2014-02-12

    Insight Instruments Recalls Cornea Coat Hydroxypropylmethylcellulose Syringes

    Insight Instruments is recalling Cornea Coat syringes because they were marketed without an approved NDA or ANDA.

    Product
    Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.
    Category
    Drug
    Distribution
    Distributed nationwide