# FDA recall D-1057-2019

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2019-03-22.

## Product

Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland  21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.

## Reason for recall

Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-1057-2019
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-22
- **Report date:** 2019-04-03
- **Termination date:** 2020-07-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baltimore, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1057-2019

## Citation

> AI Analytics. FDA recall D-1057-2019. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1057-2019. Source: US FDA. Licensed CC0.

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