Sandoz Donepezil 10mg Tablets Recall: Subpotent Drug Risk
Sandoz recalls 10mg Donepezil tablets with subpotent drug results. Affected lots expire May 2017. No remedy specified in official notice.
Lower-risk recall
Subpotent Drug: out of specification results for assay test.
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What happened, in plain English
Sandoz is recalling 10mg Donepezil Hydrochloride Tablets in 30-count and 1000-count bottles due to subpotent drug results. This means the medication may not contain the correct amount of active ingredient, potentially reducing effectiveness. Read more at govinfonow.com/recall/42130-sandoz-donepezil-10mg-tablets-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42130-sandoz-donepezil-10mg-tablets-recall-subpotent-drug-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0435-2017
Cite this page
“Sandoz Donepezil 10mg Tablets Recall: Subpotent Drug Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42130-sandoz-donepezil-10mg-tablets-recall-subpotent-drug-risk. Based on FDA recall #D-0435-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0435-2017%22&limit=1).
Why it’s dangerous
The drug test results showed the medication contains less active ingredient than specified. This could lead to reduced effectiveness in treating Alzheimer's disease symptoms. However, the recall does not indicate a risk of harm beyond reduced therapeutic benefit.
Who’s affected
People prescribed Donepezil by a doctor who received the recalled 30-count or 1000-count bottles with specific lot numbers (FJ6599 or FJ6600) expiring May 2017. Those using the medication without a prescription are not affected.
How to tell if you have this one
Check for 30-count or 1000-count bottles labeled with lot numbers FJ6599 (expiring May 2017) or FJ6600 (expiring May 2017). These tablets are prescription-only and manufactured in India by Sandoz.
- Brand
Sandoz- Category
Drug
What to do — step by step
Check Medication Details
Verify the bottle's lot number and expiration date to confirm if it matches the recalled lots (FJ6599 or FJ6600, expiring May 2017).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 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-0435-2017 (December 13, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0435-2017 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.