FDA Drug recall D-0267-2024
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 0…
- FDA Drug
- Class II
- completed
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 0… 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-0267-2024 |
| 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
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.
Reason
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Identifiers
| ndc | 47335-578-83 |
|---|---|
| ndc | 47335-578-81 |
| ndc | 47335-578-13 |
| ndc | 47335-684-83 |
| ndc | 47335-684-81 |
| ndc | 47335-684-13 |
| ndc | 47335-639-83 |
| ndc | 47335-639-81 |
| ndc | 47335-639-13 |
| ndc | 47335-685-83 |
| ndc | 47335-685-81 |
| ndc | 47335-685-13 |
| ndc | 47335-579-83 |
| ndc | 47335-579-81 |
| ndc | 47335-579-13 |
| code_info | Lot #s: DNE0621A Exp. 11/30/2024, DNE0815A Exp. 12/31/2024 |
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-0267-2024%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.