Class II · Moderate risk
Venlafaxine Tablets
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Venlafaxine Hydrochloride
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
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
Affected NDC
0904-7075-61
Compare with the code on your package — it is the most precise check available.
Drug: Venlafaxine Category: Mental Health Medication
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- NDC code
- 0904-7075-61
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0584-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Venlafaxine recalls
See all
Class III · Low risk
Venlafaxine Extended-Release Tablets
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Class II · Moderate risk
Venlafaxine Tablets
Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules USP
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
Other recalls by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
All 2024 recalls
Class II · Moderate risk
Carton Label: MAJOR
Subpotent Drug
Class II · Moderate risk
Omega-3-Acid
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Class II · Moderate risk
Memantine Hydrochloride Extended-Release
Failed Dissolution Specifications
Class II · Moderate risk
Midodrine Hydrochloride Tablets
Defective container; inadequately sealed blister packaging.
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