# FDA recall D-0638-2020

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2019-12-26.

## Product

Blisovi Fe  1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11

## Reason for recall

Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0638-2020
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-26
- **Report date:** 2020-01-15
- **Termination date:** 2020-10-22

- **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-0638-2020

## Citation

> AI Analytics. FDA recall D-0638-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0638-2020. Source: US FDA. Licensed CC0.

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