Venlafaxine Hydrochloride recall
FDA recall D-0584-2024 · initiated Jun 18, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Venlafaxine Hydrochloride in Jun 2024 — an FDA Class II recall (D-0584-2024) because Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 864 cartons
Details
- 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
- Recalling company
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide. No foreign consignees.
- Initiated
- Jun 18, 2024
- FDA report date
- Jul 10, 2024
Frequently asked
- Was Venlafaxine Hydrochloride recalled?
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Venlafaxine Hydrochloride in Jun 2024 — an FDA Class II recall (D-0584-2024) because Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Venlafaxine Hydrochloride recalled?
- Per the FDA enforcement record, the reason for recall D-0584-2024 was: Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
- Is a recalled Venlafaxine Hydrochloride dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Venlafaxine Hydrochloride are affected?
- Distributed: Nationwide. No foreign consignees.. The recall covers these lots — Lot code: M04614, Exp 09/30/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0584-2024.