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.

26–50 of 114

  • SevereFDA (Drugs)·D-1331-2020·2020-07-01

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

    Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected the impurity NDMA above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1354-2020·2020-07-01

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

    Amneal Pharmaceuticals is recalling specific lots of 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, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1352-2020·2020-07-01

    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, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1344-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

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

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1350-2020·2020-07-01

    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, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1345-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1347-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

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

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1333-2020·2020-07-01

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

    PD-Rx Pharmaceuticals is recalling 1,969 bottles of Metformin Hydrochloride Extended Release 500 mg because FDA analysis detected NDMA impurity above acceptable levels.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1356-2020·2020-07-01

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

    Time-Cap Labs is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis found NDMA impurity above acceptable levels.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    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
  • 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-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-1334-2020·2020-07-01

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

    Lupin Pharmaceuticals is recalling 6,540 bottles of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1353-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

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

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1307-2020·2020-06-24

    PD-Rx Recalls Metformin HCL ER Tablets Due to NDMA Impurity

    PD-Rx Pharmaceuticals is recalling specific lots of metformin HCL ER 500 mg tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorp
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1303-2020·2020-06-24

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

    Apotex Inc. is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1305-2020·2020-06-24

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

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

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulas
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1304-2020·2020-06-24

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

    AvKARE Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1004-2020·2020-03-18

    Precision Dose Recalls Ranitidine Oral Solution Due to NDMA Impurity

    Precision Dose Inc. is recalling Ranitidine Oral Solution because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0825-2020·2020-02-12

    Spectrum Chemical Recalls Ranitidine Hydrochloride Powder Due to NDMA Impurity

    Spectrum Laboratory Products is recalling Ranitidine Hydrochloride powder due to the presence of NDMA impurity. The product was distributed to pharmacies in 11 US states and internationally.

    Product
    Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
    Category
    Drug
    Distribution
    11 states
  • 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-0796-2020·2020-01-29

    Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity

    Preferred Pharmaceuticals is recalling 150 mg Ranitidine tablets because of detected NDMA impurity. The affected products were distributed to physicians in seven states.

    Product
    Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0791-2020·2020-01-29

    Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

    Mylan Pharmaceuticals is recalling Nizatidine Capsules 150 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

    Product
    Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
    Category
    Drug
    Distribution
    0 states
  • 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-0792-2020·2020-01-29

    Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

    Mylan Pharmaceuticals is recalling Nizatidine Capsules 300 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

    Product
    Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
    Category
    Drug
    Distribution
    0 states