Mesalamine Delayed-Release Tablets — Class II drug recall D-0268-2024
Completed recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2024-01-31, distributed nationwide. CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equip
| Recall number | D-0268-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2024-01-18 |
| Classified | 2024-01-25 |
| Reported by FDA | 2024-01-31 |
| Distributed | Nationwide (US) |
| Quantity | 10,690 bottles |
| Reason classes | microbial contamination, cgmp |
| NDC | 63304-0175, 63304-0175-13 |
| Lot numbers | DNE0875A, DNE0876A, DNE0877A, DNE1080A, DNE1081A, DNE1147A, DNE1148A |
| Expiration dates | 2025-01-31, 2025-02-28, 2025-03-31 |
Product
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.
Reason for recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
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-0268-2024. 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.