Mesalamine Extended-Release Capsules — Class II drug recall D-0350-2024
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2024-03-06, distributed nationwide. Failed Dissolution Specifications: Out of specification for dissolution.
| Recall number | D-0350-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2024-02-05 |
| Classified | 2024-02-23 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 54,960 bottles |
| Reason classes | specification failure |
| NDC | 63304-0089, 63304-0089-13 |
| Lot numbers | MHD0606A, MHD0612A, MHD0613A, MHD0652A, MHD0657A, MHD0672A, MHD0673A, MHD0767A, MHD0768A, MHD0769A, MHD0785A, MHD0799A, MHD0800A, MHD0801A, MHD0827A, MHD0828A, MHD0875A, MHD0876A, MHD0898A, MHD0901A, MHD1081A, MHD1082A, MHD1087A |
| Expiration dates | 2024-04-30, 2024-05-31, 2024-06-30, 2024-07-31, 2024-09-30 |
Product
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.
Reason for recall
Failed Dissolution Specifications: Out of specification for dissolution.
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-0350-2024. 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.