FDA Drug recall D-1294-2019
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
- FDA Drug
- Class II
- terminated
- Published 2019-05-29
On 2019-05-29 the FDA classified a Class II recall of Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60 by Mallinckrodt Pharmaceuticals, citing 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 bec….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1294-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-13 |
| Published | 2019-05-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mallinckrodt Pharmaceuticals |
| Distribution | US |
Product
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
Reason
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.
Identifiers
| ndc | 64764-080-60 |
|---|---|
| ndc | 64764-080-40 |
| ndc | 64764-240-60 |
| ndc | 64764-240-10 |
| ndc | 64764-240-40 |
| code_info | Lot #: 3229691-61, Exp 01/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1294-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.