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.

76–100 of 114

  • 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-0537-2020·2019-12-11

    Sanofi Recalls Regular Strength Zantac 150 mg Due to NDMA Impurity

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

    Product
    Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0540-2020·2019-12-11

    Sanofi Recalls Zantac 75 mg Due to NDMA Impurity

    Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets nationwide because 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 50269-222-25.
    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-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-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-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
  • SevereFDA (Drugs)·D-0310-2020·2019-11-20

    Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Novitium Pharma LLC is recalling 19,560 bottles of Ranitidine Capsules 150 mg nationwide because the product contains the NDMA impurity.

    Product
    Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0312-2020·2019-11-20

    Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Novitium Pharma LLC is recalling Ranitidine Capsules 300 mg because the product was found to contain the NDMA impurity.

    Product
    Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0309-2020·2019-11-20

    Lannett Recalls Ranitidine Syrup Due to NDMA Impurity

    Lannett Company, Inc. is recalling 683,149 bottles of Ranitidine Syrup nationwide because NDMA impurity was detected.

    Product
    Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0311-2020·2019-11-20

    Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Novitium Pharma LLC is recalling 2,718 bottles of Ranitidine Capsules 150 mg because the product contains the NDMA impurity.

    Product
    Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0308-2020·2019-11-20

    GSMS Recalls Ranitidine Capsules Due to NDMA Impurity Detection

    Golden State Medical Supply Inc. is recalling specific lots of Ranitidine Capsules 300 mg because the FDA detected the NDMA impurity in the product.

    Product
    GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0307-2020·2019-11-20

    GSMS Recalls Ranitidine Capsules Due to NDMA Impurity Detection

    Golden State Medical Supply Inc. is recalling specific lots of Ranitidine Capsules 150 mg because the FDA detected the NDMA impurity in the product.

    Product
    GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0313-2020·2019-11-20

    Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Novitium Pharma LLC is recalling Ranitidine Capsules 300 mg because of the presence of the NDMA impurity. The recall covers 6,660 bottles distributed nationwide.

    Product
    Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0174-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because of the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0180-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Capsules Due to NDMA Impurity

    Dr. Reddy's is recalling Ranitidine Hydrochloride capsules because of CGMP deviations and the presence of NDMA impurity.

    Product
    RANITIDINE HYDROCHLORIDE — RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0170-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because the presence of the NDMA impurity was detected in the product.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01) (Walgreens) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0176-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because the presence of the NDMA impurity was detected in the product.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0179-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because of the presence of NDMA impurity. The product was distributed to major distributors throughout the United States.

    Product
    Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0182-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's is recalling Ranitidine Tablets because an NDMA impurity was detected. Consumers should stop using the product and return it to the pharmacy.

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0171-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Walmart-branded Ranitidine Tablets 150 mg because of the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0183-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because of the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC
    Category
    Drug
    Distribution
    0 states