Qualitest Dexamethasone Elixir Recall: Impurities May Cause Harm
Qualitest Pharmaceuticals recalls Dexamethasone Elixir (0.5 mg/5mL, :8 fl.oz.) due to failed impurities and degradation specifications. Rx only product with NDC 0603-1147-56, lot 0000007104, exp 05/17.
Recall notice
Failed Impurities/ Degradation Specifications
Contact the company
What happened, in plain English
Qualitest Pharmaceuticals is recalling Dexamethasone Elixir (0.5 mg/5 mL, 8 fl.oz.) because it failed impurities and degradation specifications. This medication is prescription-only and may pose a risk if used improperly. Read more at govinfonow.com/recall/42088-qualitest-dexamethasone-elixir-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/42088-qualitest-dexamethasone-elixir-recall-impurities-may-cause-harm · Updated October 8, 2026 · FDA enforcement record: FDA #D-0438-2017
Cite this page
“Qualitest Dexamethasone Elixir Recall: Impurities May Cause Harm.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42088-qualitest-dexamethasone-elixir-recall-impurities-may-cause-harm. Based on FDA recall #D-0438-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0438-2017%22&limit=1).
Why it’s dangerous
The product failed impurities and degradation specifications, meaning it may contain harmful substances or break down into unsafe components. This could lead to adverse effects if the medication is used as intended.
Who’s affected
Prescription patients who have this specific Dexamethasone Elixir product. Those with medical conditions requiring this medication are most at risk.
How to tell if you have this one
Check for the product name 'Dexamethasone Elixir, USP, 0.5 mg/5 mL, 8 fl.oz.' on the label. Look for NDC 0603-1147-56 and lot number 0000007104, which expired May 2017.
- Brand
Qualitest Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Label
Look for NDC 0603-1147-56 and lot number 0000007104 on the label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0438-2017 (January 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0438-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.