# FDA recall D-0236-2017

> **Sandoz Incorporated** · Class II · drug recall initiated 2016-12-22.

## Product

Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540,  NDC 0781-1182-10

## Reason for recall

Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)

## Distribution

MS and OH.

## Key facts

- **Recall number:** D-0236-2017
- **Recalling firm:** Sandoz Incorporated
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-22
- **Report date:** 2017-01-04
- **Termination date:** 2017-09-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Broomfield, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0236-2017

## Citation

> AI Analytics. FDA recall D-0236-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0236-2017. Source: US FDA. Licensed CC0.

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