# FDA recall D-0868-2017

> **Sandoz Inc** · Class III · drug recall initiated 2017-04-26.

## Product

Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ   NDC 0781-1831-20

## Reason for recall

Subpotent Drug; Clavulanic Acid

## Distribution

NY, OH

## Key facts

- **Recall number:** D-0868-2017
- **Recalling firm:** Sandoz Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-04-26
- **Report date:** 2017-06-07
- **Termination date:** 2019-08-19

- **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-0868-2017

## Citation

> AI Analytics. FDA recall D-0868-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0868-2017. Source: US FDA. Licensed CC0.

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