Donepezil HCL Tablets 5 mg Recalled for Subpotency
Jubilant Cadista Pharmaceuticals is recalling Donepezil HCL Tablets, USP, 5 mg (Lot # DN120006A, exp. 12/2021) because the tablets are subpotent—meaning they contain less active ingredient than specified. The recall affects 14,544 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as Class III, a lower-risk category. No illnesses, injuries, or adverse events are reported in the source text. The defect is subpotency (reduced active ingredient), which is a quality issue rather than a safety hazard like contamination or toxicity.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling Donepezil HCL Tablets, USP, 5 mg in 90-count bottles (NDC 59746-329-90), manufactured by Jubilant Generics Ltd. in India. The recall applies to Lot # DN120006A with an expiration date of 12/2021.
The reason for recall is that the tablets are subpotent, meaning they contain less of the active ingredient than intended. Donepezil is used to treat symptoms of mild to moderate Alzheimer's disease.
The recalled product was distributed nationwide. A total of 14,544 bottles have been affected. This is a voluntary recall initiated by the firm on August 20, 2021, and the FDA classified it as Class III on August 31, 2021.
Patients taking this medication should contact their healthcare provider or pharmacist about their treatment and whether they have received tablets from the affected lot. The recall was terminated on April 5, 2022.
The recalled product
- Product
- Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Category
- Drug — Prescription / Tablet
- Hazard
- Affected units
- 14,544
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 # DN120006A
- exp. date 12/2021
Distribution
Distributed nationwide across the United States.
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