The Recall Desk

Hazard

Stability Data recalls

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

What the numbers show

Total
38
Critical
0
Severe
1
Most recent
2018-03-21

Of the 38 stability data 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 (3%) 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 stability data 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.

1–25 of 38

  • ModerateFDA (Drugs)·D-0591-2018·2018-03-21

    Oxytocin USP Powder Recalled Due to Insufficient Stability Data

    American Pharmaceutical Ingredients LLC is recalling Oxytocin USP powder because stability data does not support the listed expiration dates.

    Product
    Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0592-2018·2018-03-21

    American Pharmaceutical Ingredients Recalls Sermorelin Acetate Powder Due to Stability Data

    American Pharmaceutical Ingredients LLC is recalling Sermorelin Acetate powder because stability data does not support the listed expiration dates.

    Product
    Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0579-2018·2018-03-14

    Apollo Care Recalls Vancomycin IV Bags Due to Stability Data Issues

    Apollo Care is recalling 360 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.

    Product
    Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0582-2018·2018-03-14

    Kalchem Recalls Vardenafil HCl Due to Missing Stability Data

    Kalchem International is recalling Vardenafil HCl 500 GM jars due to a lack of stability data supporting the expiration date.

    Product
    Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05
    Category
    Drug
    Distribution
    1 state
  • 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-0539-2018·2018-02-28

    Fluticasone Propionate USP Recalled for Missing Stability Data

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

    Product
    Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford
    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-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-0479-2018·2018-02-28

    FDA Recalls Clindamycin Phosphate Due to Missing Stability Data

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

    Product
    Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0508-2018·2018-02-28

    Lincomycin HCl USP Recalled Due to Missing Stability Data

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

    Product
    Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g (NDC 58597-8359-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0506-2018·2018-02-28

    Lidocaine HCl USP Recalled for Missing Stability Data

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

    Product
    Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0535-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Ascorbic Acid Due to Stability Data Gaps

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

    Product
    Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) 5000g (NDC 58597-8120-9); e) 25000g (NDC 58597-8120-3), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland R
    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-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-0502-2018·2018-02-28

    FDA Recalls Levetiracetam USP for Prescription Compounding Due to Stability Issues

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

    Product
    Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7); b) 1000g (NDC 58597-8353-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0521-2018·2018-02-28

    Sumatriptan Succinate USP Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Sumatriptan Succinate USP for prescription compounding due to a lack of stability data supporting the expiration date.

    Product
    Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0531-2018·2018-02-28

    Ursodiol USP Recall Due to Missing Stability Data and Expiration Controls

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

    Product
    Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), 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-0504-2018·2018-02-28

    Levofloxacin Hemihydrate Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients is recalling Levofloxacin Hemihydrate USP for prescription compounding due to missing stability data supporting expiration dates.

    Product
    Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0509-2018·2018-02-28

    Liothyronine Sodium USP Recalled for Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Liothyronine Sodium USP for prescription compounding due to a lack of stability data supporting the expiration date.

    Product
    Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8021-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0512-2018·2018-02-28

    Nandrolone Decanoate USP Recalled for Lack of Stability Data

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

    Product
    Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); c) 500g (NDC 58597-0081-7); d) 1000g (NDC 58597-0081-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    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-0516-2018·2018-02-28

    Phentolamine Mesylate Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients LLC is recalling Phentolamine Mesylate USP for prescription compounding due to missing stability data supporting expiration dates.

    Product
    Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0490-2018·2018-02-28

    FDA Recalls Estriol USP for Prescription Compounding Due to Stability Data Issues

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

    Product
    Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c) 100g (NDC 58597-8048-6), 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