Class III · Lower riskRecall completed
Donepezil Hydrochloride Tablets
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: a) FJ6599, Exp 05/17 and b) FJ6600, Exp 05/17
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Subpotent Drug: out of specification results for assay test.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Sandoz Inc |
| NDC | 0781-5275-31 |
Show the full FDA record
| Full product label | Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540. |
| Recalling firm | Sandoz Inc |
| Distribution | Nationwide in the USA |
| Quantity | a) 10,200 bottles; b) 300 bottles |
| Recall initiated | 2016-12-13 |
| Report date | 2017-01-25 |
| Recall completed | 2017-09-14 |
| Recall number | D-0435-2017 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.