Lower riskDrug recall · FDA · Published May 13, 2019
Mallinckrodt Recalls Amitiza 8mcg Capsules Due to Labeling Mix-Up
Mallinckrodt recalls Amitiza 8mcg capsules (60-count) due to labeling mix-up where 24mcg capsules were mistakenly included in 8mcg bottles. This affects prescription-only medication.
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.
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📍Recalling firmMALLINCKRODT PHARMACEUTICALS1425 Us Highway 206 · Bedminster, NJ 07921-2653
“Mallinckrodt Recalls Amitiza 8mcg Capsules Due to Labeling Mix-Up.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38819-mallinckrodt-recalls-amitiza-8mcg-capsules-due-to-labeling-mix-up. Based on FDA recall #D-1294-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1294-2019%22&limit=1).
The FDA announced on May 13, 2019, that Mallinckrodt Pharmaceuticals is recalling Amitiza (lubiprostone) capsules due to a labeling mix-up. The agency reported that bottles labeled as containing 8 mcg strength may contain the wrong dosage.
The recall addresses a labeling mix-up where Amitiza 8 mcg capsules were found in bottles intended for the 24 mcg strength, and vice versa. The FDA classified this as a Class II recall involving 89,808 bottles distributed nationwide.
Context
GovInfoNow's records show that Mallinckrodt Pharmaceuticals has been involved in other recent recalls of similar products, including Sun Pharmaceutical Perampanel 6mg Tablets Recall (2026-06-17), Alvogen Thyro-Tabs 150mcg Tablets Recall (2025-12-31), and American Regent Levocarnitine Injection Recall (2026-04-16).
How to tell if you have this one
Check for the 8 mcg Amitiza capsules in a 60-count bottle with NDC 64764-080-60, Lot # 3229691-61, expiring January 2022. The product is prescription-only and manufactured by Sucampo Pharma Americas, LLC.
Brand
Mallinckrodt Pharmaceuticals
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1294-2019 (May 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1294-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
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