McKesson Recalls Donepezil HCl Tablets Due to Out-of-Specification Assay
McKesson Packaging Services is recalling 476 cartons of Donepezil HCl 10mg tablets because routine stability testing revealed an out-of-specification assay result.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a quality control failure (assay) rather than a direct safety hazard like contamination or mislabeling of a dangerous substance.
Plain-English summary
McKesson Packaging Services is recalling 476 cartons of Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container. The product is prescription-only and was manufactured by Sandoz, Inc. The specific lot number is 0111593, with an expiration date of 05/2017, and the NDC is 63739-678-10.
The recall was initiated because the product failed an assay test during routine stability testing, resulting in an out-of-specification finding. This indicates that the potency of the medication may not meet the required standards.
The affected product was distributed in Colorado, Louisiana, and Ohio. Consumers and healthcare providers should check their inventory for this specific lot and expiration date. If found, the product should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider regarding alternative treatment options if they have been using this specific lot.
The recalled product
- Product
- 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
- Manufacturer
- Mckesson Packaging Services
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #0111593
- Exp. 05/2017
Distribution
Related recalls
Same manufacturer · Mckesson Packaging Services
See all →- ModerateMcKesson Recalls Diltiazem CD Capsules Due to Dissolution Failures
FDA (Drugs) · 2018-05-02
- LowMcKesson Recalls Diltiazem HCl Extended-Release Capsules Due to Dissolution Failures
FDA (Drugs) · 2018-05-02
- ModerateMcKesson Recalls Diltiazem HCl Extended-Release Capsules Due to Dissolution Failures
FDA (Drugs) · 2018-05-02
- ModerateRanitidine Tablets Recalled for Failed Stability Specifications
FDA (Drugs) · 2018-03-14
- ModerateMcKesson Recalls Subpotent Megestrol Acetate Oral Suspension
FDA (Drugs) · 2018-02-14
Same hazard · out of specification
See all →- ModerateDabigatran Etexilate Capsules Recalled Over Impurity Test Failure
FDA (Drugs) · 2026-07-29
- ModerateAquacel Ag Surgical SP Surgical Dressing Recalled for Out-of-Specification Thickness
FDA (Devices) · 2026-07-15
- SevereGlucagon Emergency Kit Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2026-07-08
- HighMedline pre-connected urethral catheterization trays fail performance specifications
FDA (Devices) · 2026-06-24
- HighMedline 15 Fr urethral catheterization trays fail performance specifications
FDA (Devices) · 2026-06-24