The Recall Desk

Manufacturer

AVKARE LLC

4 recalls in our database name AVKARE LLC as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2023-09-13

Of the 4 recalls from AVKARE 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.

1–4 of 4

  • HighFDA (Drugs)·D-1147-2023·2023-09-13

    OTC Topical Cream Cartons May Contain Mislabeled Prescription Toothpaste

    Capsaicin Cream 0.025% cartons labeled as pain relief cream may contain Sodium Fluoride 1.1% prescription dental toothpaste instead. Consumers should verify product contents before use.

    Product
    CAPSAICIN — CAPSAICIN (CAPSAICIN)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1146-2023·2023-09-13

    Prescription Dental Toothpaste Recalled Due to Incorrect Carton Labeling

    AvKARE is recalling Sodium Fluoride 1.1% prescription dental toothpaste because cartons are labeled as Capsaicin Cream 0.025%, though the tubes are correctly labeled. Approximately 35,184 tubes have been distributed to 19 consignees.

    Product
    SODIUM FLOURIDE — SODIUM FLOURIDE (SODIUM FLUORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0875-2023·2023-06-21

    Tranexamic Acid tablets recalled due to failed specification testing

    AVKARE LLC is recalling Tranexamic Acid USP 650mg tablets nationwide due to failed quality control specifications for conductivity. No illnesses have been reported.

    Product
    TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0091-2023·2023-01-04

    Glycopyrrolate 1 mg Tablets Recalled for Failed Impurity Specifications

    AVKARE LLC is recalling Glycopyrrolate 1 mg tablets distributed nationwide due to failed quality specifications involving unknown impurities. The recall affects 1,237 cartons.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    Distributed nationwide