Amitiza — Class II drug recall D-1294-2019
Terminated recall by MALLINCKRODT PHARMACEUTICALS, reported 2019-05-29, distributed nationwide. Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mc
| Recall number | D-1294-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MALLINCKRODT PHARMACEUTICALS, Bedminster, NJ, United States |
| Recall initiated | 2019-05-13 |
| Classified | 2019-05-23 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2023-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 89,808 bottles |
| Reason classes | labeling |
| NDC | 64764-0080, 64764-0080-40, 64764-0080-60, 64764-0240, 64764-0240-10, 64764-0240-40, 64764-0240-60 |
| Lot numbers | 3229691-61 |
| Expiration dates | 2022-01 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1294-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.