Donepezil Hydrochloride tablets recalled for improper storage temperature
Donepezil Hydrochloride 10mg tablets are recalled due to exposure to temperatures outside labeled storage conditions. The FDA classified this Class II recall due to potential effects on drug stability.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II prescription drug recall due to CGMP deviation: products exposed to improper storage temperatures. No illnesses or injuries reported. Per rubric criterion, risk-of-harm products without reported injury warrant High (3) severity.
Plain-English summary
Cardinal Healthcare is recalling Donepezil Hydrochloride 10mg tablets, 90-count (Batch 17616), distributed nationwide. The recall was initiated because products were exposed to temperatures outside of their labeled storage conditions.
Donepezil is a prescription medication used to treat cognitive decline in Alzheimer's disease. Storage temperature deviations can affect medication stability and efficacy. This recall has been classified as Class II by the FDA.
No illnesses or injuries have been reported in connection with this recall. Patients currently taking this medication should contact their healthcare provider for guidance regarding their specific supply.
The recalled product
- Product
- DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE)
- Brand
- DONEPEZIL HYDROCHLORIDE
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Prescription
- Hazard
- improper-storage
- cgmp-deviation
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 (1)
- Batch 17616
UPCs (2)
- 0343547276034
- 0343547275037
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · DONEPEZIL HYDROCHLORIDE
- HighDonepezil Hydrochloride Tablets Recalled Due to Storage Temperature Deviations
FDA (Drugs) · 2024-01-03
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27