Allopurinol Tablet
FDA Recall NDC 55111-730
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 Allopurinol (NDC 55111-730). A significant event, classified as Class II, was initiated on Jun 07, 2024 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Presence of foreign substance."
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
Presence of foreign substance.
Jun 07, 2024
Jul 10, 2024
20,520 units
Recall Profile & Regulatory Data
Event ID
94781
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
IL, MS, OH
Termination Date
Dec 22, 2025
Product Description
Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01.
Batch or Lot Expiration Information
Lot# L2300594
Affected Packages Involved in this Recall
55111-729-01Product
55111-729-10Product
55111-730-01Product
55111-730-05Product
Class II Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Jan 26, 2022
Jan 03, 2024
1 unit
Recall Profile & Regulatory Data
Event ID
89450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CARDINAL HEALTHCARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2024
Product Description
ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106. NDC: 55111-730-05
Batch or Lot Expiration Information
Batch# Batch L100813
Affected Packages Involved in this Recall
55111-729-01Product
55111-729-10Product
55111-730-01Product
55111-730-05Product
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.
