# FDA recall D-1056-2020

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2020-03-09.

## Product

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.

## Reason for recall

Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.

## Distribution

Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-1056-2020
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-03-09
- **Report date:** 2020-03-18
- **Termination date:** 2021-05-25

- **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-1056-2020

## Citation

> AI Analytics. FDA recall D-1056-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1056-2020. Source: US FDA. Licensed CC0.

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