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.

1–25 of 114

  • SevereFDA (Drugs)·D-0385-2021·2021-05-26

    Preferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets

    Preferred Pharmaceuticals is recalling specific lots of Metformin HCl Extended Release tablets due to the presence of NDMA impurity exceeding safety limits.

    Product
    Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0249-2021·2021-02-10

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling 7,071 bottles of Metformin Hydrochloride Extended-Release Tablets, 750 mg, because the product contains N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0227-2021·2021-01-20

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets, 750 mg, because the product contains N-Nitrosodimethylamine (NDMA) above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0067-2021·2020-11-11

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg because the NDMA impurity level exceeds acceptable intake limits.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0056-2021·2020-11-11

    Denton Pharma Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Denton Pharma, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg due to the detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0060-2021·2020-11-11

    PD-Rx Recalls Metformin Hydrochloride Extended Release Tablets Due to NDMA

    PD-Rx Pharmaceuticals is recalling 125 bottles of Metformin Hydrochloride Extended Release tablets because of NDMA impurity levels above acceptable limits.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    16 states
  • SevereFDA (Drugs)·D-0062-2021·2020-11-11

    Metformin Hydrochloride Extended Release Tablets Recalled for NDMA Impurity

    Marksans Pharma Limited is recalling Metformin Hydrochloride Extended Release tablets due to N-Nitrosodimethylamine (NDMA) impurity levels above acceptable intake limits.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0059-2021·2020-11-11

    PD-Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

    PD-Rx Pharmaceuticals is recalling 1,683 bottles of Metformin Hydrochloride Extended Release 500 mg because of NDMA impurity levels above acceptable limits.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    16 states
  • SevereFDA (Drugs)·D-0061-2021·2020-11-11

    Time-Cap Labs Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Time-Cap Labs, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 500 mg because the FDA detected the impurity N-Nitrosodimethylamine (NDMA) above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0058-2021·2020-11-11

    Direct Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

    Direct Rx is recalling 88 bottles of Metformin Hydrochloride Extended Release 500 mg in Florida due to NDMA impurity levels above acceptable intake.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0068-2021·2020-11-11

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling 20,872 bottles of Metformin Hydrochloride Extended-Release Tablets 500 mg because they contain N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0057-2021·2020-11-11

    Denton Pharma Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Denton Pharma, Inc. is recalling specific bottles of Metformin Hydrochloride Extended-Release Tablets 500 mg because they contain N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, N
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0050-2021·2020-11-04

    RemedyRepack Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

    RemedyRepack Inc. is recalling Metformin Hydrochloride Extended Release 750 mg tablets because of detected NDMA impurity levels above acceptable intake limits.

    Product
    Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0016-2021·2020-10-14

    Direct Rx Recalls Ranitidine 150 mg Tablets Due to NDMA Impurity

    Direct Rx is recalling specific lots of Ranitidine 150 mg tablets because an NDMA impurity was detected. The affected products were distributed in Florida and Georgia.

    Product
    Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0017-2021·2020-10-14

    Direct Rx Recalls Ranitidine 300 mg Tablets Due to NDMA Impurity

    Direct Rx is recalling 26 bottles of Ranitidine 300 mg tablets because the product was found to contain the NDMA impurity.

    Product
    Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0002-2021·2020-10-07

    Sun Pharmaceuticals Recalls RIOMET ER Due to NDMA Impurity

    Sun Pharmaceuticals is recalling RIOMET ER (metformin hydrochloride) oral suspension because it contains the impurity NDMA.

    Product
    RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1382-2020·2020-07-22

    Lupin Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected NDMA impurity above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1384-2020·2020-07-22

    Lupin Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1385-2020·2020-07-22

    Lupin Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1386-2020·2020-07-22

    Granules Pharmaceuticals Recalls Metformin Hydrochloride Extended-Release Tablets

    Granules Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets due to FDA detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.

    Product
    METFORMIN — METFORMIN (METFORMIN ER 500 MG)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1383-2020·2020-07-22

    Lupin Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1360-2020·2020-07-08

    Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    The Harvard Drug Group is recalling Metformin Hydrochloride Extended-Release Tablets due to potential NDMA impurity levels above established limits.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1349-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected NDMA impurity above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1348-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1393-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
    Category
    Drug
    Distribution
    Distributed nationwide