Mckesson Donepezil Tablets Recall: Out of Specification Assay Test Results
Mckesson Packaging Services recalls Donepezil HCl 10mg tablets with out of specification assay test results from stability testing. This medication is prescription-only and distributed via specific lot numbers.
Recall notice
Supotent: Out of Specification result for assay test during routine stability testing.
Contact the company
What happened, in plain English
Mckesson Packaging Services has recalled Donepezil HCl 10mg tablets that failed stability testing. The issue means the medication may not contain the correct amount of active ingredient, which could affect treatment effectiveness. Read more at govinfonow.com/recall/42099-mckesson-donepezil-tablets-recall-out-of-specification-assay-test-results.
Source Summary by GovInfoNow · govinfonow.com/recall/42099-mckesson-donepezil-tablets-recall-out-of-specification-assay-test-results · Updated October 8, 2026 · FDA enforcement record: FDA #D-0680-2017
Cite this page
“Mckesson Donepezil Tablets Recall: Out of Specification Assay Test Results.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42099-mckesson-donepezil-tablets-recall-out-of-specification-assay-test-results. Based on FDA recall #D-0680-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0680-2017%22&limit=1).
Why it’s dangerous
The tablets failed a routine stability test, indicating the medication may not contain the correct amount of active ingredient. This could lead to treatment being less effective than intended. However, the recall does not specify if this affects safety or causes harm.
Who’s affected
Prescription patients who received Donepezil HCl 10mg tablets with lot number 0111593 from McKesson Packaging Services. Patients using this medication for Alzheimer's disease or other related conditions are most at risk.
How to tell if you have this one
Check for Donepezil HCl 10mg tablets in 10x10 blister packs per carton (100 unit dose) with lot number 0111593. The medication is prescription-only and distributed by McKesson Packaging Services.
- Brand
Mckesson Packaging Services- Category
Drug
What to do — step by step
Check Medication Details
Verify the lot number on the packaging; if it matches 0111593, the product is recalled.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “CO, LA and OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado, Louisiana, Ohio.
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.
Questions people ask
When was this product manufactured?
The product was manufactured with lot number 0111593, which expired on May 2017.
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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-0680-2017 (January 4, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0680-2017 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.