Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Amitiza (lubiprostone) capsules Recalled by MALLINCKRODT PHARMACEUTICALS Due to Labeling: Label mix-up. Amitiza 8 mcg capsules are...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact MALLINCKRODT PHARMACEUTICALS directly.
Affected Products
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
Quantity: 89,808 bottles
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About MALLINCKRODT PHARMACEUTICALS
MALLINCKRODT PHARMACEUTICALS has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report