# FDA recall D-805-2013

> **Sandoz Incorporated** · Class II · drug recall initiated 2013-06-21.

## Product

Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only,   Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15

## Reason for recall

Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.

## Distribution

Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.

## Key facts

- **Recall number:** D-805-2013
- **Recalling firm:** Sandoz Incorporated
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-21
- **Report date:** 2013-07-24
- **Termination date:** 2014-01-29

- **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-805-2013

## Citation

> AI Analytics. FDA recall D-805-2013. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-805-2013. Source: US FDA. Licensed CC0.

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