Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported November 21, 2018
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan, encapsulated in the United States. NDC 64764-080-60
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Takeda Development Center Americas, Inc. recalled AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pha… - a low-severity action.
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pha… was recalled by Takeda Development Center Americas, Inc. in November 21, 2018. Reason: Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sa…. Check the official notice for the remedy. Verify recall #D-0286-2019 with the FDA Drug before acting.
The recall
Takeda Development Center Americas, Inc. issued this low-severity FDA Drug recall-Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sa….
- Low
- severity level
- Class III
- classification
- November 21, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0286-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0286-2019) was formally reported on November 21, 2018, with the manufacturer initiating the action on November 6, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Takeda Development Center Americas, Inc. is listed as the recalling firm, operating out of Deerfield, IL. Federal records list the affected scope as 69,075 60-count bottles (4,144,500 capsules).
The documented reason for this recall is: Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing. Distribution data in the federal record shows the product reached: Product was distributed to 32 distributors throughout the United States.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
69,075 60-count bottles (4,144,500 capsules)
Related Recalls
6
0 from same agency
Product description
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan, encapsulated in the United States. NDC 64764-080-60
Reason for recall
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0286-2019 |
| Date reported | November 21, 2018 |
| Date initiated | November 6, 2018 |
| Recalling firm | Takeda Development Center Americas, Inc. |
| Firm location | Deerfield, IL |
| Affected scope | 69,075 60-count bottles (4,144,500 capsules) |
| Distribution | Product was distributed to 32 distributors throughout the United States. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0286-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan, encapsulated in the United States. NDC 64764-080-60. Recalled by Takeda Development Center Americas, Inc.. Units affected: 69,075 60-count bottles (4,144,500 capsules).
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 21, 2018. Severity: Low. Recall number: D-0286-2019.
Where was the recalled product distributed? ▼
Distribution: Product was distributed to 32 distributors throughout the United States..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0286-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported November 21, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.