The Recall Desk

Hazard

Incomplete Stability Studies recalls

6 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2023-06-07

Of the 6 incomplete stability studies recalls 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 hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all incomplete stability studies 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.

1–6 of 6

  • HighFDA (Drugs)·D-0785-2023·2023-06-07

    Artificial Tears Solution Recalled Due to CGMP Deviations and Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Artificial Tears Solution (Polyvinyl Alcohol 1.4%) nationwide due to CGMP compliance issues and inability to complete required stability studies after the firm went out of business.

    Product
    Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0798-2023·2023-06-07

    FDA Recalls DetomiSed Drug Due to Incomplete Stability Testing

    FDA is recalling all lots of DetomiSed (detomidine hydrochloride), a prescription-only drug, nationwide. Akorn Inc., the manufacturer, went out of business and could no longer conduct stability studies.

    Product
    DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0853-2023·2023-06-07

    Akorn Tropicamide Ophthalmic Solution Recalled for Manufacturing Quality Deviations

    Akorn recalls all lots of Tropicamide Ophthalmic Solution 0.5% (15 mL bottles) nationwide due to CGMP deviations. The firm was unable to complete required stability studies after ceasing operations.

    Product
    Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0793-2023·2023-06-07

    Cimetidine HCl Oral Solution Recalled Due to Manufacturing Compliance Deviations

    Akorn, Inc. is recalling all lots of Cimetidine HCl Oral Solution 300mg/5mL nationwide due to CGMP deviations. The firm ceased operations and could not complete required stability studies.

    Product
    Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0856-2023·2023-06-07

    XOPENEX Inhalation Solution Recalled Due to Manufacturing Compliance Issues

    Akorn, Inc. is recalling all lots of XOPENEX (levalbuterol HCl) inhalation solution because the company went out of business and cannot continue required stability studies. The firm's manufacturing deviations affect product safety verification.

    Product
    XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2023·2023-06-07

    Ropivacaine Hydrochloride Injection Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Ropivacaine Hydrochloride Injection USP 0.5% nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required FDA testing.

    Product
    Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide