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.

1026–1050 of 1563

  • SevereFDA (Drugs)·D-0643-2020·2020-01-15

    Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

    Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 300 mg because the FDA detected the NDMA impurity in the product.

    Product
    Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0648-2020·2020-01-15

    Appco Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Appco Pharma LLC is recalling Ranitidine Capsules 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0640-2020·2020-01-15

    Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

    Glenmark Pharmaceuticals is recalling 217,956 bottles of Ranitidine Tablets USP 150 mg nationwide because the product contains the NDMA impurity.

    Product
    Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0632-2020·2020-01-08

    Ranitidine Tablets Recalled Due to NDMA Impurity

    Granules India Limited is recalling Ranitidine tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0615-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0612-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0617-2020·2019-12-18

    Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity

    Preferred Pharmaceuticals is recalling specific lots of Ranitidine Tablets 150 mg because the FDA detected the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0613-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Tablets 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0616-2020·2019-12-18

    Amneal Recalls Ranitidine Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine 300 mg tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0545-2020·2019-12-11

    Sanofi Recalls Zantac 75 mg Tablets Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Zantac 75 mg tablets nationwide because NDMA impurity was detected. The recall covers all lots of the product.

    Product
    Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0536-2020·2019-12-11

    Sanofi Recalls Maximum Strength Zantac 150 mg Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Maximum Strength Zantac 150 mg tablets nationwide because an NDMA impurity was detected in the product.

    Product
    Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0541-2020·2019-12-11

    Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 150 mg tablets nationwide because an NDMA impurity was detected. This action addresses current good manufacturing practice (CGMP) deviations.

    Product
    Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0535-2020·2019-12-11

    Sanofi Recalls Zantac 75 mg Tablets Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets nationwide because NDMA impurity was detected. This action addresses CGMP deviations.

    Product
    Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0534-2020·2019-12-11

    Sanofi Recalls Zantac Tablets Due to NDMA Impurity

    Sanofi is recalling Cool Mint Tablets Maximum Strength Zantac 150 mg nationwide because NDMA impurity was detected in the product.

    Product
    Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0544-2020·2019-12-11

    Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Zantac 150 mg tablets nationwide because an NDMA impurity was detected in the product.

    Product
    Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0542-2020·2019-12-11

    Sanofi Recalls Regular Strength Zantac 75 mg Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets because the FDA detected the NDMA impurity in the product.

    Product
    Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0543-2020·2019-12-11

    Sanofi Recalls Zantac 75 mg Due to NDMA Impurity

    Sanofi is recalling Regular Strength Zantac 75 mg tablets nationwide because an NDMA impurity was detected in the product.

    Product
    Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0539-2020·2019-12-11

    Sanofi Recalls Maximum Strength Zantac 150 mg Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Maximum Strength Zantac 150 mg tablets nationwide because the FDA detected the NDMA impurity in the product.

    Product
    Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0597-0121-11, 0597-0121-24, 0597-0121-38, 0597-0121-50, 0597-0121-64, 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0526-2020·2019-12-04

    AuroMedics Recalls Ranitidine Tablets Due to NDMA Detection

    AuroMedics Pharma LLC is recalling DG Health Acid Reducer Ranitidine Tablets 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.

    Product
    DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0525-2020·2019-12-04

    AVKARE Recalls Ranitidine Tablets Due to NDMA Impurity

    AVKARE Inc. is recalling specific lots of Ranitidine Tablets 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0524-2020·2019-12-04

    AVKARE Recalls Ranitidine Tablets Due to NDMA Impurity

    AVKARE Inc. is recalling specific lots of Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0503-2020·2019-11-27

    Washington Homeopathic Products Recalls Silicea 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling 426 bottles of Silicea 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Silicea 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64199 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0493-2020·2019-11-27

    Washington Homeopathic Recalls Calcarea Sulphurica 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling Calcarea Sulphurica 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Calcarea Sulphurica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64190 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0497-2020·2019-11-27

    Washington Homeopathic Products Recalls Kali Phosphoricum 6X Tablets for CGMP Deviations

    Washington Homeopathic Products, Inc. is recalling 417 bottles of Kali Phosphoricum 6X Tablets because they were not manufactured under current good manufacturing practices.

    Product
    Kali Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64195 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0504-2020·2019-11-27

    Washington Homeopathic Products Recalls Pareira Tincture for Manufacturing Deviations

    Washington Homeopathic Products is recalling Pareira (Brava) 1X Tincture because it was not manufactured under current good manufacturing practices.

    Product
    Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide