Pentasa — Class III drug recall D-0432-2017
Terminated recall by Shire PLC, reported 2017-01-25, distributed nationwide. Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
| Recall number | D-0432-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shire PLC, Lexington, MA, United States |
| Recall initiated | 2016-12-02 |
| Classified | 2017-01-17 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2018-06-01 |
| Distributed | Nationwide (US) |
| Quantity | 4,520 bottles |
| Reason classes | labeling |
| NDC | 54092-0189, 54092-0189-81, 54092-0191, 54092-0191-12 |
| Lot numbers | AE7363A |
| Expiration dates | 2019-06-30 |
Product
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
Reason for recall
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0432-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.