Recall: Amerisource Health Levofloxacin 500mg Tablets Due to Dissolution Failure
Amerisource Health Services is recalling specific lots of Levofloxacin Tablets USP, 500 mg due to failed dissolution specifications. Check your lot number and expiration date.
Use caution until it’s fixed
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Contact the company
What happened, in plain English
Amerisource Health Services has recalled Levofloxacin Tablets USP, 500 mg because the product failed to meet dissolution specifications. This means the medication may not release its active ingredient properly in the body. The recall affects 3,888 cartons distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/43219-recall-amerisource-health-levofloxacin-500mg-tablets-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/43219-recall-amerisource-health-levofloxacin-500mg-tablets-due-to-dissolution-failure · Updated October 11, 2026 · FDA enforcement record: FDA #D-0610-2016
Cite this page
“Recall: Amerisource Health Levofloxacin 500mg Tablets Due to Dissolution Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43219-recall-amerisource-health-levofloxacin-500mg-tablets-due-to-dissolution-failure. Based on FDA recall #D-0610-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0610-2016%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, resulting in low out-of-specification results. This failure mechanism suggests the drug might not dissolve correctly, potentially leading to reduced effectiveness in treating infections.
Who’s affected
Patients who have been prescribed Levofloxacin Tablets USP, 500 mg by a healthcare provider. Individuals who purchased the specific recalled lots may receive medication that does not work as intended.
How to tell if you have this one
Look for Levofloxacin Tablets USP, 500 mg packaged in 100-count (10 x 10) blister cards per carton. Check for individual blisters labeled with UPC (01) 003 68084 482 11 3 and cartons labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4. Identify Lot # 151387 with an expiration date of 10/31/16.
- Brand
Amerisource Health Services- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Levofloxacin Tablets match the recalled lot number 151387 and expiration date 10/31/16.
Contact Healthcare Provider
Speak with your doctor or pharmacist to determine if you should continue taking the medication or switch prescriptions.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0610-2016 (January 18, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0610-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.