# FDA recall D-1502-2020

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2020-07-21.

## Product

Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each, NDC: 68180-911-13, Distributed by: Lupin Pharmaceuticals, Inc., MD, 21200, Manufactured by: Lupin Limited, India.

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.

## Distribution

Nationwide within the U.S.

## Key facts

- **Recall number:** D-1502-2020
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-07-21
- **Report date:** 2020-08-19
- **Termination date:** 2022-01-21

- **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-1502-2020

## Citation

> AI Analytics. FDA recall D-1502-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1502-2020. Source: US FDA. Licensed CC0.

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