Carvedilol Tablet, Film Coated
FDA Recall NDC 68382-092
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 Carvedilol (NDC 68382-092). A significant event, classified as Class II, was initiated on Aug 13, 2021 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle"
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
August 2021 Class II Recall: Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Recall Number
Class II Terminated
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Aug 13, 2021
Aug 25, 2021
2880 bottles
Recall Profile & Regulatory Data
Event ID
88482
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Apr 03, 2023
Product Description
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
Batch or Lot Expiration Information
Lot# Z006279, exp 12/31/2022
Affected Packages Involved in this Recall
68382-092-17Product
68382-092-01Product
68382-092-05Product
68382-093-17Product
68382-093-05Product
68382-093-01Product
68382-094-17Product
68382-094-01Product
68382-094-05Product
68382-095-17Product
68382-095-01Product
68382-095-05Product
April 2019 Class II Recall: Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Recall Number
Class II Terminated
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Apr 25, 2019
May 15, 2019
3900
Recall Profile & Regulatory Data
Event ID
82714
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 29, 2021
Product Description
Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05
Batch or Lot Expiration Information
Lot# Z804517, exp Nov 30, 2020
Affected Packages Involved in this Recall
68382-092-17Product
68382-092-01Product
68382-092-05Product
68382-093-17Product
68382-093-05Product
68382-093-01Product
68382-094-17Product
68382-094-01Product
68382-094-05Product
68382-095-17Product
68382-095-01Product
68382-095-05Product
Class III Terminated
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Apr 22, 2019
May 01, 2019
7668 bottles
Recall Profile & Regulatory Data
Event ID
82682
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jan 14, 2021
Product Description
Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05
Batch or Lot Expiration Information
Lot# : Z803518, Exp 08/2020
Affected Packages Involved in this Recall
68382-092-17Product
68382-092-01Product
68382-092-05Product
68382-093-17Product
68382-093-05Product
68382-093-01Product
68382-094-17Product
68382-094-01Product
68382-094-05Product
68382-095-17Product
68382-095-01Product
68382-095-05Product
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.
