Venlafaxine Tablet
FDA Recall NDC 68382-101
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Venlafaxine (NDC 68382-101). A significant event, classified as Class II, was initiated on Mar 21, 2025 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Mar 21, 2025
Apr 16, 2025
13,128 100-Count Bottles
Recall Profile & Regulatory Data
Event ID
96553
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.
Batch or Lot Expiration Information
Lot# : M314265, Exp.: 31 October 2025.
Affected Packages Involved in this Recall
68382-018-06Product
68382-018-14Product
68382-018-16Product
68382-018-01Product
68382-018-05Product
68382-018-10Product
68382-019-06Product
68382-019-14Product
68382-019-16Product
68382-019-01Product
68382-019-05Product
68382-019-10Product
68382-020-06Product
68382-020-14Product
68382-020-16Product
68382-020-01Product
68382-020-05Product
68382-020-10Product
68382-021-06Product
68382-021-14Product
68382-021-16Product
68382-021-01Product
68382-021-05Product
68382-021-10Product
68382-101-06Product
68382-101-14Product
68382-101-16Product
68382-101-01Product
68382-101-05Product
68382-101-10Product
Class II Terminated
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Mar 05, 2013
Apr 03, 2013
13,320 bottles
Recall Profile & Regulatory Data
Event ID
64604
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
May 04, 2015
Product Description
Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01.
Batch or Lot Expiration Information
Lot# : MM8490, Exp 09/14
Affected Packages Involved in this Recall
68382-018-06Product
68382-018-14Product
68382-018-16Product
68382-018-01Product
68382-018-05Product
68382-018-10Product
68382-019-06Product
68382-019-14Product
68382-019-16Product
68382-019-01Product
68382-019-05Product
68382-019-10Product
68382-020-06Product
68382-020-14Product
68382-020-16Product
68382-020-01Product
68382-020-05Product
68382-020-10Product
68382-021-06Product
68382-021-14Product
68382-021-16Product
68382-021-01Product
68382-021-05Product
68382-021-10Product
68382-101-06Product
68382-101-14Product
68382-101-16Product
68382-101-01Product
68382-101-05Product
68382-101-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
