# FDA recall D-854-2013

> **Sandoz Incorporated** · Class III · drug recall initiated 2013-08-07.

## Product

Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36

## Reason for recall

Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card

## Distribution

Nationwide

## Key facts

- **Recall number:** D-854-2013
- **Recalling firm:** Sandoz Incorporated
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-08-07
- **Report date:** 2013-08-14
- **Termination date:** 2014-07-07

- **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-854-2013

## Citation

> AI Analytics. FDA recall D-854-2013. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-854-2013. Source: US FDA. Licensed CC0.

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