Venlafaxine HCL ER Capsule USP — Class II drug recall D-1461-2016
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2016-08-24, distributed nationwide. Failed Dissolution Specifications: out of specification dissolution results in retained samples
| Recall number | D-1461-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2016-07-19 |
| Classified | 2016-08-18 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2020-09-21 |
| 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 | 2017-10, 2017-11, 2017-12 |
Product
Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.
Reason for recall
Failed Dissolution Specifications: out of specification dissolution results in retained samples
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-1461-2016. 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.