The Recall Desk

Hazard

Unapproved Manufacturing recalls

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

What the numbers show

Total
3
Critical
0
Severe
1
Most recent
2013-11-27

Of the 3 unapproved manufacturing recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (33%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unapproved manufacturing 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.

1–3 of 3

  • SevereFDA (Drugs)·D-011-2014·2013-11-27

    Greenstone Recalls Spironolactone Tablets Due to Unapproved Manufacturing Site Change

    Greenstone LLC is recalling 4,848 bottles of Spironolactone 50 mg tablets because the manufacturing site change resulted in an unapproved dissolution profile.

    Product
    Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-010-2014·2013-11-27

    Greenstone Recalls Spironolactone Tablets Due to Unapproved Manufacturing Site Change

    Greenstone LLC is recalling 2,796 bottles of Spironolactone 25 mg tablets because they were manufactured at an unapproved site, altering the dissolution profile.

    Product
    Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-014-2014·2013-11-27

    Pfizer Recalls Aldactone Tablets Due to Unapproved Manufacturing Site

    Pfizer is recalling Aldactone (spironolactone) 100 mg tablets because the manufacturing site change resulted in an unapproved dissolution profile.

    Product
    ALDACTONE — ALDACTONE (SPIRONOLACTONE)
    Category
    Drug
    Distribution
    Distributed nationwide