Shire Pentasa 250mg Capsules Recall: 500mg Tablets Found
Shire recalls Pentasa 250mg capsules due to 500mg tablets mistakenly included. Check your bottle label and contact Shire for details.
Lower-risk recall
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Contact the company
What happened, in plain English
Shire is recalling Pentasa 250mg controlled-release capsules because some bottles contain 500mg tablets instead of 250mg. This could lead to incorrect dosing if taken without checking. Read more at govinfonow.com/recall/42141-shire-pentasa-250mg-capsules-recall-500mg-tablets-found.
Source Summary by GovInfoNow · govinfonow.com/recall/42141-shire-pentasa-250mg-capsules-recall-500mg-tablets-found · Updated October 8, 2026 · FDA enforcement record: FDA #D-0432-2017
Cite this page
“Shire Pentasa 250mg Capsules Recall: 500mg Tablets Found.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42141-shire-pentasa-250mg-capsules-recall-500mg-tablets-found. Based on FDA recall #D-0432-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0432-2017%22&limit=1).
Why it’s dangerous
The capsules are labeled as 250mg but contain 500mg tablets. If taken without verifying the dose, this could cause an overdose. The risk is low because the product is prescription-only and the error is in the manufacturing process.
Who’s affected
People prescribed Pentasa 250mg capsules by a doctor who received this specific bottle. Those taking the medication without checking the label are at risk of incorrect dosing.
How to tell if you have this one
Check for the label 'Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only' and the lot number AE7363A (expiring 06/30/2019).
- Brand
Shire- Category
Drug
What to do — step by step
Check Capsule Label
Look for the label 'Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only' and the lot number AE7363A.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0432-2017 (December 2, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0432-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.