Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Donepezil Hydrochloride Tablets Recalled by Sandoz Inc Due to Subpotent Drug: out of specification results for assay...

Date: December 13, 2016
Company: Sandoz Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sandoz Inc directly.

Affected Products

Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.

Quantity: a) 10,200 bottles; b) 300 bottles

Why Was This Recalled?

Subpotent Drug: out of specification results for assay test.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sandoz Inc

Sandoz Inc has 30 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report