Venlafaxine Hydrochloride Extended-Release Capsules — Class II drug recall D-0617-2024
Terminated recall by Zydus Pharmaceuticals (USA) Inc, reported 2024-07-31, distributed nationwide. Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour
| Recall number | D-0617-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2024-06-21 |
| Classified | 2024-07-23 |
| Reported by FDA | 2024-07-31 |
| Terminated | 2025-08-06 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 68382-0034, 68382-0034-06, 68382-0034-10, 68382-0034-16, 68382-0035, 68382-0035-06, 68382-0035-10, 68382-0035-16, 68382-0036, 68382-0036-06, 68382-0036-10, 68382-0036-16 |
| Expiration dates | 2024-09 |
Product
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
Reason for recall
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
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-0617-2024. 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.