Venlafaxine Hydrochloride Capsule, Extended Release
FDA Recall NDC 68382-034
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Venlafaxine Hydrochloride (NDC 68382-034). A significant event, classified as Class II, was initiated on Jun 21, 2024 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Jun 21, 2024
Jul 31, 2024
a) 13,128 bottles; b) 252 bottles
Recall Profile & Regulatory Data
Event ID
94850
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Aug 06, 2025
Product Description
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
Batch or Lot Expiration Information
Lot# : a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
Affected Packages Involved in this Recall
68382-034-06Product
68382-034-16Product
68382-034-10Product
68382-035-06Product
68382-035-16Product
68382-035-10Product
68382-036-06Product
68382-036-16Product
68382-036-10Product
Class II Terminated
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Jul 19, 2016
Aug 24, 2016
223,776 bottles
Recall Profile & Regulatory Data
Event ID
74753
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 21, 2020
Product Description
Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.
Batch or Lot Expiration Information
Lot# : a) MR10518, Exp. 9/2017; MR11051, MR11052, MR11053, MR11054, Exp. 10/2017; MR11403, Exp. 11/2017.
Lot# : b) MR10197, MR10195, Exp. 09/2017; MR11482, Exp.10/2017; MR11479, MR11480, MR11481, MR11483, MR11665 Exp. 11/2017.
Lot# : c) MR10404, MR10406, MR10521, Exp. 09/2017; MR10744, MR11055, MR11228, MR11287, MR11285, MR11288, MR11289, MR11286, Exp.10/2017; MR11567, Exp.11/2017.
Affected Packages Involved in this Recall
68382-034-06Product
68382-034-16Product
68382-034-10Product
68382-035-06Product
68382-035-16Product
68382-035-10Product
68382-036-06Product
68382-036-16Product
68382-036-10Product
Class II Terminated
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Jul 19, 2016
Aug 24, 2016
N/A
Recall Profile & Regulatory Data
Event ID
74753
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 21, 2020
Product Description
Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.
Batch or Lot Expiration Information
Lot# : a) MS1217, MS1218 , Exp.12/2017.
Lot# : b) MS1215, Exp.12/2017
Lot# : c) MR11150, MR11151, MR11854, Exp. 10/2017; MR11798, MR11799, MS1214, Exp.11/2017
Affected Packages Involved in this Recall
68382-034-06Product
68382-034-16Product
68382-034-10Product
68382-035-06Product
68382-035-16Product
68382-035-10Product
68382-036-06Product
68382-036-16Product
68382-036-10Product
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.
