Amerisource Health Recalls Candesartan Cilexetil 16mg Tablets
Amerisource Health Services recalls 16 mg Candesartan Cilexetil tablets due to failed impurity specifications. Check lot #153855.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Contact the company
What happened, in plain English
Amerisource Health Services is recalling one lot of Candesartan Cilexetil Tablets, 16 mg, because the product failed impurity and degradation specifications during a 9-month stability test. The recall affects 716 cartons distributed nationwide. No specific remedy or return instructions are provided in this record. Read more at govinfonow.com/recall/43210-amerisource-health-recalls-candesartan-cilexetil-16mg-tablets.
Source Summary by GovInfoNow · govinfonow.com/recall/43210-amerisource-health-recalls-candesartan-cilexetil-16mg-tablets · Updated October 11, 2026 · FDA enforcement record: FDA #D-0660-2016
Cite this page
“Amerisource Health Recalls Candesartan Cilexetil 16mg Tablets.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43210-amerisource-health-recalls-candesartan-cilexetil-16mg-tablets. Based on FDA recall #D-0660-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0660-2016%22&limit=1).
Why it’s dangerous
The tablets failed to meet specifications for impurities and degradation after 9 months of stability testing. This means the chemical composition of the drug may have changed over time, potentially affecting its safety or effectiveness, although specific health outcomes are not detailed in the record.
Who’s affected
Patients currently taking Candesartan Cilexetil 16 mg prescribed by a doctor, specifically those who may have received the recalled lot from pharmacies across the United States. Individuals with high blood pressure or heart failure are the primary users of this medication.
How to tell if you have this one
Check your medication bottle for NDC 68084-877-25 (carton) or NDC 68084-877-95 (individual dose). Verify that the Lot number is 153855 and the expiration date is 01/2017. The product was distributed by American Health Packaging in Columbus, Ohio.
- Brand
Amerisource Health Services- Category
Drug
What to do — step by step
Contact Your Pharmacist
Call the pharmacy where you filled your prescription to confirm if your specific bottle matches the recalled lot number and NDC codes.
Consult Your Doctor
Speak with your healthcare provider before stopping or changing your medication dosage to ensure your treatment plan remains safe.
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 12 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-0660-2016 (January 26, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0660-2016 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.