The Recall Desk

Manufacturer

American Pharmaceutical Ingredients LLC

71 recalls in our database name American Pharmaceutical Ingredients LLC as the manufacturing or recalling firm.

What the numbers show

Total
71
Critical
0
Severe
3
Most recent
2018-03-21

Of the 71 recalls from American Pharmaceutical Ingredients LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 71

  • 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-0533-2018·2018-02-28

    FDA Recalls Vardenafil HCl for Prescription Compounding Due to Stability Data Gaps

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

    Product
    Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
  • SevereFDA (Drugs)·D-0537-2018·2018-02-28

    FDA Recalls Methylcobalamin Due to Missing Stability Data

    American Pharmaceutical Ingredients LLC is recalling Methylcobalamin (Vitamin B12) for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

    Product
    Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8056-2); c) 5g (NDC 58597-8056-3); d) 10g (NDC 58597-8056-4), e) 25 g (NDC 58597-8056-4); f) 100g (NDC 58597-8056-6), RX only, packed by American Pharmaceutical I
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0529-2018·2018-02-28

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

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

    Product
    Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6); c) 500g (NDC 58597-8032-7); d)1000g (NDC 58597-8032-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2018·2018-02-28

    FDA Recalls Doxycycline Hyclate Due to Missing Stability Data

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

    Product
    Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-4); b) 100g (NDC 58597-8082-6); c) 500g (NDC 58597-8082-7); d) 1000g (NDC 58597-8082-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0526-2018·2018-02-28

    FDA Recalls Testosterone Cypionate Due to Missing Stability Data

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

    Product
    Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), 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-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-0475-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Anastrozole USP Due to Stability Data Deficiencies

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

    Product
    Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0503-2018·2018-02-28

    Levocetirizine Dihydrochloride Recalled for Lack of Stability Data

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

    Product
    Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    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-0527-2018·2018-02-28

    FDA Recalls Testosterone Enanthate USP Due to Missing Stability Data

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

    Product
    Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), 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-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-0534-2018·2018-02-28

    Verapamil HCl USP Recalled for Missing Stability Data and Controls

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

    Product
    Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); c) 1000g (NDC 58597-8039-8), 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-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-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-0497-2018·2018-02-28

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

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

    Product
    Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (NDC 58597-8133-6); d) 1000g (NDC 58597-8133-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 483
    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-0505-2018·2018-02-28

    American Pharmaceutical Ingredients Recalls Levothyroxine Sodium Due to Stability Data Deficiencies

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

    Product
    Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide