Methylphenidate Hydrochloride Tablet, Chewable
FDA Recall NDC 64980-221
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 64980-221). A significant event, classified as Class II, was initiated on Feb 07, 2022 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
Feb 07, 2022
Mar 02, 2022
2220 100-count bottles
Recall Profile & Regulatory Data
Event ID
89545
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
RISING PHARMACEUTICALS
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01
Batch or Lot Expiration Information
Lot# 25910009, Exp 01/2023
Affected Packages Involved in this Recall
64980-221-01Product
64980-222-01Product
64980-223-01Product
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.
