CLASS III Drug recall · Reported 25 Jan 2017 · FDA Enforcement Report
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg recalled
Shire is recalling Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, distributed nationwide in the US. The recall was initiated on 2 Dec 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0432-2017
- FDA event ID
- 75880
- Recalling firm
- Shire, Lexington, MA
- Brand
- Pentasa
- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Dec 2016
- FDA classified
- 17 Jan 2017
- Reported
- 25 Jan 2017
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
Timeline
| 2 Dec 2016 | Recall initiated by company | |
| 17 Jan 2017 | Classified by FDA | +46 days |
| 25 Jan 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Product as listed by the FDA
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Which lots are affected?
Lot Number AE7363A, exp 06/30/2019
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Kalbitor (ecallantide), 10mg/mL recalled by ShireKalbitor | Shire | Particulate Matter | Nationwide |
| Drug | CLASS III | Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg recalled by ShireVyvanse | Shire | Other | Nationwide |
Other Mesalamine recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mesalamine Extended-Release Capsules, USP 500mg recalledMesalamine | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Mesalamine Delayed-Release Tablets, USP per tablet recalledMesalamine | SUN Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Mesalamine Delayed-Release Tablets recalled by Teva Pharmaceuticals UMesalamine | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Mesalamine Delayed-Release Tablets, USP (Once-Daily) recalled by AVKARE | Avkare | Potency & Assay | Nationwide |
| Drug | CLASS II | Mesalamine Delayed-Release Tablets recalled by Teva Pharmaceuticals UMesalamine | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |