Atenolol Tablet
FDA Recall NDC 60429-026
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Atenolol (NDC 60429-026). A significant event, classified as Class I, was initiated on Sep 29, 2022 by Golden State Medical Supply, Inc.. The reported reason for this action was: "Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets"
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
September 2022 Class I Recall: Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Recall Number
Class I Terminated
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Sep 29, 2022
Nov 02, 2022
2,584 Bottles
Recall Profile & Regulatory Data
Event ID
90909
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Mar 20, 2025
Product Description
Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10
Batch or Lot Expiration Information
Lot# : GS046745, Exp 12/2023
Affected Packages Involved in this Recall
60429-025-90Product
60429-025-10Product
60429-026-90Product
60429-026-10Product
60429-027-90Product
60429-027-10Product
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.
