Amitiza Capsules Recalled Due to Labeling Mix-Up Between Strengths
Mallinckrodt Pharmaceuticals is recalling Amitiza capsules because 24 mcg capsules were found in 8 mcg bottles and vice versa.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling mix-up between different strengths of the same medication, which fits the criteria for moderate severity involving labeling errors.
Plain-English summary
Mallinckrodt Pharmaceuticals is recalling Amitiza (lubiprostone) capsules due to a labeling mix-up. The recall involves 80,640 bottles of 24 mcg capsules, specifically Lot # 3200626-61 with an expiration date of 02/2022. The product is distributed nationwide in the United States.
The recall was initiated because 24 mcg capsules were found in bottles labeled as 8 mcg, and sealed 60-count bottles labeled as 24 mcg contained only 8 mcg capsules. This incident is being treated as a labeling mix-up issue.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The affected product is a prescription-only medication manufactured by Sucampo Pharma Americas, LLC.
The recalled product
- Product
- AMITIZA (LUBIPROSTONE)
- Brand
- AMITIZA
- Manufacturer
- MALLINCKRODT PHARMACEUTICALS
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 80,640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 3200626-61
- Exp 02/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by MALLINCKRODT PHARMACEUTICALS under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · AMITIZA
- ModerateMallinckrodt Recalls Amitiza Capsules Due to Labeling Mix-Up
FDA (Drugs) · 2019-05-29
- LowTakeda Recalls Amitiza Capsules Due to Elevated Impurity Levels
FDA (Drugs) · 2018-11-21
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