traZODONE Hydrochloride Tablets — Class III drug recall D-0247-2026
Ongoing recall by Zydus Pharmaceuticals (USA) Inc, reported 2026-01-07, distributed nationwide. Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain sid
| Recall number | D-0247-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2025-12-19 |
| Classified | 2025-12-31 |
| Reported by FDA | 2026-01-07 |
| Distributed | Nationwide (US) |
| NDC | 68382-0609, 68382-0609-01, 68382-0609-05, 68382-0609-10, 68382-0610, 68382-0610-01, 68382-0610-05, 68382-0610-10, 68382-0805, 68382-0805-01, 68382-0805-05, 68382-0805-06, 68382-0805-10, 68382-0805-16, 68382-0805-30, 68382-0805-77, 68382-0806, 68382-0806-01, 68382-0806-05, 68382-0806-06, 68382-0806-10, 68382-0806-16, 68382-0806-30, 68382-0806-77, 68382-0807 and 15 more |
| Lot numbers | EA00237A |
| Expiration dates | 2027-04-30 |
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 for recall
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
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-0247-2026. 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.