Methylphenidate Hydrochloride Tablet
FDA Recall NDC 57664-229
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 Methylphenidate Hydrochloride (NDC 57664-229). A significant event, classified as Class II, was initiated on Jul 13, 2023 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Presence of Foreign Substance: Metal embedded in a tablet."
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: Metal embedded in a tablet.
Jul 13, 2023
Aug 02, 2023
7313 bottles
Recall Profile & Regulatory Data
Event ID
92680
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 12, 2024
Product Description
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.
Batch or Lot Expiration Information
Lot# Lot AC74459, Exp 07/31/2024
Affected Packages Involved in this Recall
57664-228-83Product
57664-228-88Product
57664-228-08Product
57664-228-13Product
57664-228-18Product
57664-229-83Product
57664-229-88Product
57664-229-08Product
57664-229-13Product
57664-229-18Product
57664-230-83Product
57664-230-88Product
57664-230-08Product
57664-230-13Product
57664-230-18Product
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.
