The Recall Desk

Hazard

Ndma Impurity recalls

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

What the numbers show

Total
114
Critical
0
Severe
113
Most recent
2021-05-26

Of the 114 ndma impurity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 113 (99%) 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 ndma impurity 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.

51–75 of 114

  • SevereFDA (Drugs)·D-0795-2020·2020-01-29

    Denton Pharma Recalls Ranitidine Tablets Due to NDMA Impurity

    Denton Pharma is recalling 467 bottles of Ranitidine Tablets 300 mg because of the presence of NDMA impurity. The affected products were distributed nationwide.

    Product
    Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0793-2020·2020-01-29

    Ranitidine Tablets Recalled Due to NDMA Impurity Detection

    H.J. Harkins Company is recalling specific lots of Ranitidine 150 mg tablets because NDMA impurity was detected. The product was distributed to physicians in four states.

    Product
    Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60
    Category
    Drug
    Distribution
    4 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-0646-2020·2020-01-15

    AAA Pharmaceutical Recalls Ranitidine Tablets Due to NDMA Impurity

    AAA Pharmaceutical is recalling specific lots of Ranitidine 150 mg tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0641-2020·2020-01-15

    Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

    Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 300 mg because of the presence of the NDMA impurity.

    Product
    Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0644-2020·2020-01-15

    Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

    Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 150 mg because testing detected the presence of the NDMA impurity.

    Product
    Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0645-2020·2020-01-15

    AAA Pharmaceutical Recalls Ranitidine Tablets Due to NDMA Impurity

    AAA Pharmaceutical is recalling Ranitidine 150 mg tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0642-2020·2020-01-15

    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 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0639-2020·2020-01-15

    Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

    Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 150 mg because the product contains the NDMA impurity.

    Product
    Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60
    Category
    Drug
    Distribution
    0 states
  • 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-0649-2020·2020-01-15

    Appco Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Appco Pharma LLC is recalling specific lots of Ranitidine Capsules 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0631-2020·2020-01-08

    American Health Packaging Recalls Ranitidine Syrup Due to NDMA Impurity

    American Health Packaging is recalling specific lots of Ranitidine Syrup because the presence of the NDMA impurity was detected in the product.

    Product
    Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-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-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-0614-2020·2019-12-18

    Amneal Recalls Ranitidine Syrup Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Ranitidine Syrup Oral Solution because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
    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-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-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-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-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-0538-2020·2019-12-11

    Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity

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

    Product
    Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7
    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