# FDA recall D-0435-2017

> **Sandoz Inc** · Class III · drug recall initiated 2016-12-13.

## Product

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.

## Reason for recall

Subpotent Drug: out of specification results for assay test.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0435-2017
- **Recalling firm:** Sandoz Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-13
- **Report date:** 2017-01-25
- **Termination date:** 2017-09-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0435-2017

## Citation

> AI Analytics. FDA recall D-0435-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0435-2017. Source: US FDA. Licensed CC0.

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