The Recall Desk

Hazard

Stability Data Lack 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
0
Severe
1
Most recent
2018-02-28

Of the 5 stability data lack 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 (20%) 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 stability data lack 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

  • SevereFDA (Drugs)·D-0488-2018·2018-02-28

    FDA Recalls Estradiol USP for Compounding Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Estradiol USP (Micronized) (Yam) for prescription compounding due to a lack of stability data and controls to support assigned expiration dates.

    Product
    Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8047-1); b) 5g (NDC 58597-8047-3); c) 10g (NDC 58597-8047-4); d) 25g (NDC 58597-8047-5); e) 100 g (NDC 58597-8047-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highl
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0482-2018·2018-02-28

    Cyclosporine USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Cyclosporine USP for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.

    Product
    Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g, NDC 58597-8210-6; d) 500g (NDC 58597-8210-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0478-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Celecoxib USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Celecoxib USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

    Product
    Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0511-2018·2018-02-28

    Naltrexone HCl USP Recalled Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Naltrexone HCl USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

    Product
    Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407-2); c) 25g (NDC 58597-8407-4); d) 100g (NDC 58597-8407-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0522-2018·2018-02-28

    Sumatriptan USP for Prescription Compounding Recalled Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Sumatriptan USP for prescription compounding due to a lack of stability data and controls to support assigned expiration dates.

    Product
    Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide