CLASS III Drug recall · Reported 25 Jan 2017 · FDA Enforcement Report
Donepezil Hydrochloride Tablets, 10 mg recalled by Sandoz
Sandoz is recalling Donepezil Hydrochloride Tablets, 10 mg, distributed nationwide in the US. The recall was initiated on 13 Dec 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0435-2017
- FDA event ID
- 75987
- Recalling firm
- Sandoz, Princeton, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Dec 2016
- FDA classified
- 19 Jan 2017
- Reported
- 25 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 13 Dec 2016 | Recall initiated by company | |
| 19 Jan 2017 | Classified by FDA | +37 days |
| 25 Jan 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: out of specification results for assay test.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Subpotent Drug: out of specification results for assay test.
Which lots are affected?
Lot #: a) FJ6599, Exp 05/17 and b) FJ6600, Exp 05/17
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Donepezil recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Donepezil HCl Tablets, 10 mg recalled by Cardinal HealthcareDonepezil Hydrochloride | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Donepezil HCl Tablets, 5 mg recalled by Cardinal HealthcareDonepezil Hydrochloride | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Donepezil HCL Tablets, USP, 5 mg recalled by Jubilant Cadista | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Donepezil HCl tablets, 10mg recalled by Mckesson Packaging Services | Mckesson Packaging Services | Potency & Assay | CO, LA, OH |