Venlafaxine Hydrochloride extended release capsules — Class II drug recall D-0474-2017
Terminated recall by Aurobindo Pharma USA Inc, reported 2017-02-22, distributed nationwide. Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
| Recall number | D-0474-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc, Plainsboro, NJ, United States |
| Recall initiated | 2016-12-22 |
| Classified | 2017-02-13 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2019-03-19 |
| Distributed | Nationwide (US) |
| Quantity | 47,040 bottles |
| NDC | 65862-0527, 65862-0527-01, 65862-0527-10, 65862-0527-30, 65862-0527-47, 65862-0527-59, 65862-0527-90, 65862-0527-99, 65862-0528, 65862-0528-01, 65862-0528-10, 65862-0528-30, 65862-0528-35, 65862-0528-47, 65862-0528-90, 65862-0528-99, 65862-0697, 65862-0697-01, 65862-0697-05, 65862-0697-10, 65862-0697-26, 65862-0697-30, 65862-0697-47, 65862-0697-90 |
| Lot numbers | VI3716010-A |
| Expiration dates | 2018-04 |
Product
Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30
Reason for recall
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
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-0474-2017. 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.