Jubilant Cadista Pharmaceuticals Donepezil HCL Tablets Recall

Why it was recalled

Subpotent

Product description

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

Lot numbers, UPCs & expiration codes

Lot # DN120006A, exp. date 12/2021

Where it was sold

Product was distributed nationwide.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0784-2021
Classification: Class III
Status: Terminated
Recall initiated: Aug 20, 2021
FDA report date: Sep 8, 2021
Quantity: 14,544 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Jubilant Cadista Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0784-2021, exactly as published.

Show all FDA fields

City: Salisbury
State: MD
Status: Terminated
Country: United States
Event ID: 88523
Address: 207 Kiley Dr
Code information: Lot # DN120006A, exp. date 12/2021
Postal code: 21801-2249
Report date: Sep 8, 2021
Product type: Drugs
Recall number: D-0784-2021
Classification: Class III
Recalling firm: Jubilant Cadista Pharmaceuticals, Inc.
Product quantity: 14,544 bottles
Termination date: Apr 5, 2022
Reason for recall: Subpotent
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Product was distributed nationwide.
Recall initiation date: Aug 20, 2021
Initial firm notification: Letter
Center classification date: Aug 31, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0784-2021, published Sep 8, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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