The Recall Desk

Manufacturer

Padagis US LLC

8 recalls in our database name Padagis US LLC as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2026-07-22

Of the 8 recalls from Padagis US LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–8 of 8

  • ModerateFDA (Drugs)·D-0677-2026·2026-07-22

    Nystatin Cream Recall Due to Low Potency Test Results

    Padagis US LLC is recalling Nystatin Cream USP (100,000 USP units) because long-term stability testing found assay results below specification, meaning the product may contain less active ingredient than labeled.

    Product
    NYSTATIN — NYSTATIN (NYSTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0246-2025·2025-03-05

    Estradiol Gel Recalled Nationwide for Defective Packet Sealing

    Padagis US LLC recalls Estradiol Gel 0.1% nationwide due to defective packets that may not be fully sealed, potentially allowing ethanol loss.

    Product
    Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0048-2025·2024-11-27

    Triamcinolone Acetonide Cream USP Recalled for Out-of-Specification Potency Variance

    Padagis is recalling 10,872 jars of Triamcinolone Acetonide Cream USP 0.025% nationwide because some jars contain subpotent or superpotent active ingredient levels. The defect was discovered during long-term stability testing.

    Product
    Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0139-2024·2023-12-13

    FDA Recalls Trospium Chloride Extended-Release Capsules for Manufacturing Defect

    Padagis US LLC is recalling Trospium Chloride Extended-Release Capsules (60 mg) due to manufacturing defects where some capsules contain missing, broken, or extra tablets. The recall affects 7,032 bottles distributed nationwide.

    Product
    TROSPIUM CHLORIDE — TROSPIUM CHLORIDE (TROSPIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0081-2024·2023-11-08

    Gynazole 1 Butoconazole Vaginal Cream Recalled for Formulation Error

    Padagis US LLC is recalling Gynazole 1 butoconazole nitrate vaginal cream nationwide due to a manufacturing error where hydrophilic colloidal silica was used instead of hydrophobic colloidal silica.

    Product
    GYNAZOLE 1 — GYNAZOLE 1 (BUTOCONAZOLE NITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0464-2023·2023-03-22

    Evamist (Estradiol) Transdermal Spray Recalled for Failed Content Uniformity

    Padagis US LLC is recalling 43,238 cartons of Evamist (Estradiol) transdermal spray nationwide because the spray content uniformity specification for standard deviation was not met at the 18-month stability time point.

    Product
    EVAMIST — EVAMIST (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1497-2022·2022-09-07

    Triamcinolone Acetonide Cream Recalled for Manufacturing Defects

    Padagis US LLC is recalling 57,816 tubes of Triamcinolone Acetonide Cream 0.1% nationwide due to manufacturing process deviations. Consumers reported gritty texture and reduced effectiveness.

    Product
    TRIAMCINOLONE ACETONIDE — TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0372-2022·2022-01-19

    Nitroglycerin Lingual Spray Recalled for Defective Delivery System

    Padagis US LLC is recalling Nitroglycerin Lingual Spray due to a defective delivery system that may prevent proper medication administration. The recall affects 11,868 bottles distributed nationwide.

    Product
    NITROGLYCERIN LINGUAL — NITROGLYCERIN LINGUAL (NITROGLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide