Qualitest Hydroxyzine Recall: Impurity Risk in Oral Solution
Qualitest recalls specific lots of Hydroxyzine Oral Solution due to high levels of a known impurity. Check your bottle's lot number and expiration date immediately.
Recall notice
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
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What happened, in plain English
Qualitest Pharmaceuticals is recalling specific lots of Hydroxyzine Hydrochloride Oral Solution because testing showed high levels of a known impurity at the 12-month mark. The recall affects 73,746 bottles distributed nationwide. The record does not specify what consumers should do with the product or provide a remedy. Read more at govinfonow.com/recall/48648-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-hydroxyzine-hydrochloride-oral.
Source Summary by GovInfoNow · govinfonow.com/recall/48648-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-hydroxyzine-hydrochloride-oral · Updated October 13, 2026 · FDA enforcement record: FDA #D-1417-2012
Cite this page
“Qualitest Hydroxyzine Recall: Impurity Risk in Oral Solution.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48648-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-hydroxyzine-hydrochloride-oral. Based on FDA recall #D-1417-2012 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1417-2012%22&limit=1).
Why it’s dangerous
The recalled solution contains high levels of a known impurity that exceeded specifications at the 12-month room temperature time point. The record does not describe the specific health effects or injury mechanism associated with this impurity.
Who’s affected
Consumers who purchased Hydroxyzine Oral Solution from pharmacies across the United States between the manufacturing date and July 6, 2012. Patients relying on these specific lot numbers are at risk of receiving a product with out-of-specification impurities.
How to tell if you have this one
Check your bottle for NDC 0603-1310-58 and UPC 3 0603-1310-58 4. Verify if your lot number is one of the following: L030F11A, L054F11A, L095E10A, L079J10A, L085K11A, L086K11A, L087G10A, L087K11A, L088K11A, L094L10A, or L100L10B. Note the expiration dates associated with these lots, which range from May 2013 to January 2014.
- Brand
Qualitest Pharmaceuticals- Product
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals recalls HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only,…- Category
Drug
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 17 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-1417-2012 (July 6, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1417-2012 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.