CLASS III Drug recall · Reported 3 May 2017 · FDA Enforcement Report
Donepezil HCl tablets, 10mg recalled by Mckesson Packaging Services
Mckesson Packaging Services is recalling Donepezil HCl tablets, 10mg, distributed in Colorado, Louisiana, Ohio. The recall was initiated on 4 Jan 2017 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-0680-2017
- FDA event ID
- 77110
- Recalling firm
- Mckesson Packaging Services, Concord, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Jan 2017
- FDA classified
- 25 Apr 2017
- Reported
- 3 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 4 Jan 2017 | Recall initiated by company | |
| 25 Apr 2017 | Classified by FDA | +111 days |
| 3 May 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Supotent: Out of Specification result for assay test during routine stability testing.
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 HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC 63739-678-10
Where it was distributed
CO, LA and OH.
Questions about this recall
Is Donepezil HCl tablets, 10mg recalled?
Yes. Mckesson Packaging Services recalled Donepezil HCl tablets, 10mg on 4 Jan 2017. The recall is Class III and its status is Terminated. Recall number D-0680-2017.
Why was it recalled?
Supotent: Out of Specification result for assay test during routine stability testing.
Which lots are affected?
Lot #0111593, Exp. 05/2017
Where was it sold?
CO, LA and OH.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mckesson Packaging Services
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Diltiazem HCl Extended-Release Capsules, USP 120 mg recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem HCl Extended-Release Capsules, USP 240 mg recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem CD (Diltiazem Hydrochloride Extended-Release recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Ranitidine Tablets, USP 150 mg UD recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Megestrol Acetate Oral Suspension, USP 400 mg/ UD cups in boxes recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
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 Hydrochloride Tablets, 10 mg recalled by Sandoz | Sandoz | Potency & Assay | Nationwide |