# FDA recall D-0838-2018

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2018-05-17.

## Product

My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD  21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4.

## Reason for recall

Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0838-2018
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-05-17
- **Report date:** 2018-05-30
- **Termination date:** 2019-05-01

- **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-0838-2018

## Citation

> AI Analytics. FDA recall D-0838-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0838-2018. Source: US FDA. Licensed CC0.

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