# FDA recall D-1294-2019

> **MALLINCKRODT PHARMACEUTICALS** · Class II · drug recall initiated 2019-05-13.

## Product

Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60

## Reason for recall

Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.

## Distribution

US Nationwide

## Key facts

- **Recall number:** D-1294-2019
- **Recalling firm:** MALLINCKRODT PHARMACEUTICALS
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-13
- **Report date:** 2019-05-29
- **Termination date:** 2023-07-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bedminster, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1294-2019

## Citation

> AI Analytics. FDA recall D-1294-2019. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-1294-2019. Source: US FDA. Licensed CC0.

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