FDA Drug recall D-0247-2026
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus…
- FDA Drug
- Class III
- ongoing
- Published 2026-01-07
On 2026-01-07 the FDA classified a Class III recall of traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus… by Zydus Pharmaceuticals Usa, citing failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0247-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-12-19 |
| Published | 2026-01-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
Reason
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Identifiers
| ndc | 68382-805-01 |
|---|---|
| ndc | 68382-805-30 |
| ndc | 68382-805-77 |
| ndc | 68382-805-05 |
| ndc | 68382-805-10 |
| ndc | 68382-805-06 |
| ndc | 68382-805-16 |
| ndc | 68382-806-06 |
| ndc | 68382-806-16 |
| ndc | 68382-806-01 |
| ndc | 68382-806-05 |
| ndc | 68382-806-10 |
| ndc | 68382-806-30 |
| ndc | 68382-806-77 |
| ndc | 68382-807-06 |
| ndc | 68382-807-16 |
| ndc | 68382-807-01 |
| ndc | 68382-807-05 |
| ndc | 68382-807-10 |
| ndc | 68382-807-30 |
| ndc | 68382-807-77 |
| ndc | 68382-808-06 |
| ndc | 68382-808-16 |
| ndc | 68382-808-01 |
| ndc | 68382-808-05 |
| ndc | 68382-808-10 |
| ndc | 68382-808-30 |
| ndc | 68382-808-77 |
| ndc | 68382-609-01 |
| ndc | 68382-609-05 |
| ndc | 68382-609-10 |
| ndc | 68382-610-01 |
| ndc | 68382-610-05 |
| ndc | 68382-610-10 |
| code_info | Lot # EA00237A, Exp Date: 04/30/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0247-2026%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.