“Jubilant Cadista recalls Donepezil 5mg tablets: Subpotent risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/35900-jubilant-cadista-recalls-donepezil-5mg-tablets-subpotent-risk. Based on FDA recall #D-0784-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0784-2021%22&limit=1).
The FDA announced on August 20, 2021, that Jubilant Cadista Pharmaceuticals Inc. voluntarily recalled Donepezil HCL Tablets, USP, 5 mg, 90-count bottles due to subpotency hazards. The recall was classified as Class III and has since been terminated.
The recalled Donepezil HCL Tablets are subpotent, meaning they may not contain the labeled amount of active ingredient. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Jubilant Cadista Pharmaceuticals, Inc. has had 24 other recalls on record since February 11, 2013. Other recent recalls include the December 27, 2022 subpotent drug risk for Prochlorperazine Tablets, the July 18, 2022 failed dissolution specs for 75mg Irbesartan tablets, and the April 1, 2022 subpotent risk for Methylprednisolone Tablets. Other recent recalls of similar products include Unichem busPIRone 5mg Tablets (April 13, 2026), Hikma Ramipril Capsules 10mg (August 24, 2026), and Ajanta Pharma Fluphenazine Tablets (August 25, 2026).
How to tell if you have this one
Check for the 5mg Donepezil tablets in a 90-count bottle with NDC code 59746-329-90 and lot number DN120006A. The product is only available through prescription.
Brand
Jubilant Cadista
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the NDC code 59746-329-90 and lot number DN120006A on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Product was distributed 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 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0784-2021 (August 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0784-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.