Overview

AvKARE, Inc. is a leading provider in the pharmaceutical distribution sector, specializing in servicing the healthcare needs for hospitals, healthcare facilities, and the government. As a private company, AvKARE has established a reputation for quality and reliability in the distribution of pharmaceuticals.

Therapeutic areas

FDA compliance signals

50 FDA enforcement records linked to this company.

  • recall — Class II2026-03-04

    Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.

  • recall — Class II2026-01-14

    Out of specification for dissolution.

  • recall — Class II2025-10-15

    Failed Content Uniformity Specifications

  • recall — Class II2025-09-17

    Presence of a foreign substance.

  • recall — Class II2025-09-17

    Presence of a foreign substance.

  • recall — Class III2025-07-09

    Failed Impurity/Degradation Specifications

  • recall — Class III2025-07-09

    Failed Impurity/Degradation Specifications

  • recall — Class II2025-06-18

    Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules

  • recall — Class II2025-06-18

    Failed Dissolution Specifications

  • recall — Class II2025-02-26

    Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)

  • recall — Class II2025-02-19

    Out of Specification for Dissolution

  • recall — Class II2025-01-08

    Failed Dissolution Specifications

  • recall — Class III2025-01-08

    LABELING: LABEL MIX-UP

  • recall — Class III2025-01-08

    LABELING: LABEL MIX-UP

  • recall — Class II2024-12-11

    Labeling: Label Mix-Up

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