# FDA recall D-1565-2019

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2019-07-02.

## Product

Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc.  Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton of 3 wallets)

## Reason for recall

Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1565-2019
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-07-02
- **Report date:** 2019-08-07
- **Termination date:** 2021-02-16

- **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-1565-2019

## Citation

> AI Analytics. FDA recall D-1565-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-1565-2019. Source: US FDA. Licensed CC0.

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