Venlafaxine Hydrochloride — Class II drug recall D-0584-2024
Terminated recall by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, reported 2024-07-10, distributed nationwide. Failed dissolution specifications: out of specification result obtained during routine stability testing for h
| Recall number | D-0584-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, La Vergne, TN, United States |
| Recall initiated | 2024-06-18 |
| Classified | 2024-07-03 |
| Reported by FDA | 2024-07-10 |
| Terminated | 2025-12-22 |
| Distributed | Nationwide (US) |
| Quantity | 864 cartons |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00309047075614 |
| NDC | 00904-7075-61 |
| Lot numbers | M04614 |
| Expiration dates | 2024-09-30 |
Product
Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614
Reason for recall
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
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-0584-2024. 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.