# FDA recall D-0790-2020

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2020-01-10.

## Product

Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)

## Reason for recall

CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.

## Distribution

Distributed nationwide in the US

## Key facts

- **Recall number:** D-0790-2020
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-01-10
- **Report date:** 2020-01-22
- **Termination date:** 2021-06-03

- **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-0790-2020

## Citation

> AI Analytics. FDA recall D-0790-2020. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0790-2020. Source: US FDA. Licensed CC0.

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