The Recall Desk

Hazard

Cgmp Deviation recalls

1,563 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,563
Critical
1
Severe
288
Most recent
2026-09-09

Of the 1,563 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 288 (18%) 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 cgmp deviation 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.

1301–1325 of 1563

  • ModerateFDA (Drugs)·D-0692-2018·2018-05-02

    Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints

    Time-Cap Laboratories is recalling specific lots of Ibuprofen 800 mg tablets due to odor complaints linked to CGMP deficiencies.

    Product
    IBUPROFEN — IBUPROFEN (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0583-2018·2018-03-14

    Spirit Pharmaceuticals Recalls Valumeds Ibuprofen Due to CGMP Deviations

    Spirit Pharmaceuticals is recalling 144 bottles of Valumeds Ibuprofen 200 mg in New York due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    VALUMEDS IBUPROFEN — VALUMEDS IBUPROFEN (IBUPROFEN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0494-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Gabapentin USP for Prescription Compounding

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

    Product
    Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC 58597-8014-7); d) 1000g (NDC 58597-8014-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0492-2018·2018-02-28

    Fluconazole USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Fluconazole USP for prescription compounding due to CGMP deviations involving missing stability data and controls.

    Product
    Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0514-2018·2018-02-28

    Oxandrolone USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Oxandrolone USP for prescription compounding due to CGMP deviations, specifically a lack of stability data and controls to support expiration dates.

    Product
    Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)100g (NDC 58597-0082-6); c) 500g (NDC 58597-0082-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0520-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Stanozolol USP Due to CGMP Deviations

    American Pharmaceutical Ingredients LLC is recalling Stanozolol USP for prescription compounding due to lack of stability data and controls supporting expiration dates.

    Product
    Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7); d)1000g (NDC 58597-8525-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0487-2018·2018-02-28

    FDA Recalls Duloxetine HCl for Prescription Compounding Due to Stability Data Deficiencies

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

    Product
    Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6); b)1000 g (NDC 58597-8632-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0481-2018·2018-02-28

    Cyclobenzaprine HCl USP Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Cyclobenzaprine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0525-2018·2018-02-28

    FDA Recalls Testosterone for Compounding Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Testosterone (Soy) (Micronized) USP for prescription compounding due to a lack of stability data and controls supporting expiration dates.

    Product
    Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2018·2018-02-28

    Ketoprofen USP Micronized Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Ketoprofen USP (Micronized) for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336-6); c) 500g (NDC 58597-8336-7); d) 1000g (NDC 58597-8336-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 4832
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0496-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Imiquimod USP Due to Stability Data Deficiencies

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

    Product
    Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (NDC 58597-8317-4) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0510-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Medroxyprogesterone Acetate Due to Stability Data Gaps

    American Pharmaceutical Ingredients is recalling 12,000 grams of Medroxyprogesterone Acetate USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration date.

    Product
    Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Water ford, MI 48327, NDC 58597-8055-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0480-2018·2018-02-28

    Clonidine HCl USP Recalled Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Clonidine HCl USP for prescription compounding because it lacks stability data to support its expiration date.

    Product
    Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-8010-2); b) 10g (NDC 58597-8010-3); c) 25g (NDC 58597-8010-4); d)100g (NDC 58597-8010-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Nifedipine USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Nifedipine USP for prescription compounding because it lacks stability data to support its expiration dates.

    Product
    Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    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-0530-2018·2018-02-28

    FDA Recalls Tretinoin USP for Prescription Compounding Due to Stability Data Gaps

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

    Product
    Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0524-2018·2018-02-28

    Tadalafil USP Recall Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Tadalafil USP for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highlan
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0528-2018·2018-02-28

    FDA Recalls Testosterone USP Micronized for Prescription Compounding

    American Pharmaceutical Ingredients LLC is recalling Testosterone USP (Micronized) (Yam) for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.

    Product
    Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0517-2018·2018-02-28

    Prilocaine HCl USP Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Prilocaine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g (NDC 58597-8028-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0476-2018·2018-02-28

    Baclofen USP Micronized Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Baclofen USP (Micronized) for prescription compounding due to a lack of stability data supporting expiration dates.

    Product
    Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6); c) 500g (NDC 58597-8004-7); d) 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0518-2018·2018-02-28

    Progesterone USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Progesterone USP for prescription compounding due to CGMP deviations involving missing stability data and controls.

    Product
    Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), RX only
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0499-2018·2018-02-28

    Ketoconazole USP Recalled for Lack of Stability Data and Controls

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

    Product
    Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) 100g (NDC 58597-8053-6); c) 500g (NDC 58597-8053-7) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0536-2018·2018-02-28

    Biotin USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Biotin USP for prescription compounding due to CGMP deviations, specifically a lack of stability data and controls to support expiration dates.

    Product
    Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g (NDC 58597-8142-3); d ) 25g (NDC 58597-8142-4), Rx only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0483-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Desoximetasone USP Due to Stability Data Deficiencies

    American Pharmaceutical Ingredients LLC is recalling Desoximetasone USP (Micronized) for prescription compounding due to a lack of stability data and controls supporting the expiration date.

    Product
    Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8634-2.
    Category
    Drug
    Distribution
    Distributed nationwide