# FDA recall D-1384-2012

> **Teva Pharmaceuticals USA, Inc.** · Class III · drug recall initiated 2012-04-23.

## Product

Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.

## Reason for recall

Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1384-2012
- **Recalling firm:** Teva Pharmaceuticals USA, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-04-23
- **Report date:** 2012-06-27
- **Termination date:** 2013-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sellersville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1384-2012

## Citation

> AI Analytics. FDA recall D-1384-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1384-2012. Source: US FDA. Licensed CC0.

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