The Recall Desk

Manufacturer

Denton Pharma, Inc.

4 recalls in our database name Denton Pharma, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
4
Most recent
2020-11-11

Of the 4 recalls from Denton Pharma, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (100%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • 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-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-0794-2020·2020-01-29

    Denton Pharma Recalls Ranitidine Tablets Due to NDMA Impurity

    Denton Pharma is recalling 1,341 bottles of Ranitidine Tablets 150 mg because the product was found to contain the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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