FDA Drug recall D-0432-2017
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC…
- FDA Drug
- Class III
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class III recall of Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC… by Shire, citing presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0432-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-12-02 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Shire |
| Distribution | US |
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
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Identifiers
| ndc | 54092-189-81 |
|---|---|
| ndc | 54092-191-12 |
| code_info | Lot Number AE7363A, exp 06/30/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0432-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.