# FDA recall D-268-2013

> **Sandoz Incorporated** · Class II · drug recall initiated 2013-04-18.

## Product

Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only.  Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.

## Reason for recall

Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-268-2013
- **Recalling firm:** Sandoz Incorporated
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-04-18
- **Report date:** 2013-05-01
- **Termination date:** 2014-02-26

- **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-268-2013

## Citation

> AI Analytics. FDA recall D-268-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-268-2013. Source: US FDA. Licensed CC0.

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