FDA Drug recall D-0269-2024
Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,…
- FDA Drug
- Class II
- completed
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,… by Sun Pharmaceutical Industries, citing CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0269-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2024-01-18 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, 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 47335-613-81.
Reason
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Identifiers
| ndc | 47335-539-83 |
|---|---|
| ndc | 47335-539-81 |
| ndc | 47335-539-88 |
| ndc | 47335-539-08 |
| ndc | 47335-539-18 |
| ndc | 47335-614-83 |
| ndc | 47335-614-81 |
| ndc | 47335-614-88 |
| ndc | 47335-614-18 |
| ndc | 47335-613-83 |
| ndc | 47335-613-81 |
| ndc | 47335-613-88 |
| ndc | 47335-613-08 |
| ndc | 47335-613-18 |
| code_info | Lot #: DNE0788A Exp. 07/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0269-2024%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.