Venlafaxine Extended-Release Capsules Recalled for Failed Dissolution
The FDA is recalling Venlafaxine Hydrochloride extended-release capsules (37.5mg) distributed nationwide because routine stability testing revealed the capsules failed to meet dissolution specifications, potentially affecting drug effectiveness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard relates to failed drug dissolution specifications affecting medication efficacy rather than direct toxicity or contamination, placing this in the Moderate category.
Plain-English summary
The FDA is recalling Venlafaxine Hydrochloride extended-release capsules, USP, 37.5mg, manufactured by Cadila Healthcare Ltd. in Ahmedabad, India and distributed by The Harvard Drug Group LLC (dba Major Pharmaceuticals and Rugby Laboratories) nationwide. The recall affects 864 cartons with lot code M04614, expiring 09/30/2024.
The recall was initiated because routine stability testing revealed that the capsules failed to meet dissolution specifications, meaning they may not dissolve properly in the body. This could result in reduced effectiveness of the medication.
Patients currently taking this medication should contact their healthcare provider or pharmacist before discontinuing use. Do not stop taking Venlafaxine without medical guidance, as abrupt discontinuation can cause adverse effects. Patients with prescriptions for this lot should consult their pharmacist about obtaining a replacement or alternative.
The recalled product
- 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
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Drug — Antidepressant
- Hazard
- dissolution-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot code: M04614
- Exp 09/30/2024
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- ModerateVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27