Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Pentasa (mesalamine) Controlled-Release Capsules Recalled by Shire PLC Due to Presence of Foreign Tablets/Capsules; 500 mg capsules were...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Shire PLC directly.
Affected Products
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
Quantity: 4,520 bottles
Why Was This Recalled?
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Shire PLC
Shire PLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report