Methylphenidate Hydrochloride Tablet, Extended Release
FDA Recall NDC 13811-708
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Methylphenidate Hydrochloride (NDC 13811-708). A significant event, classified as Class II, was initiated on Jun 17, 2024 by Trigen Laboratories, Llc. The reported reason for this action was: "Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications."
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
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Jun 17, 2024
Jul 10, 2024
10,448 100-count bottles
Recall Profile & Regulatory Data
Event ID
94818
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Trigen Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 23, 2025
Product Description
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
Batch or Lot Expiration Information
Lot# Lot 230159M, Exp Date 2/28/2026
Affected Packages Involved in this Recall
13811-709-10Product
13811-706-10Product
13811-707-10Product
13811-708-10Product
13811-710-10Product
13811-710-30Product
Class III Terminated
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Feb 28, 2018
Mar 14, 2018
19,664 100-bottles
Recall Profile & Regulatory Data
Event ID
79365
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Osmotica Pharmaceutical Corp
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
May 01, 2019
Product Description
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
Batch or Lot Expiration Information
Lot# Lots: 170231B, 170232A, 170233A, 170234A
Affected Packages Involved in this Recall
13811-709-10Product
13811-706-10Product
13811-707-10Product
13811-708-10Product
13811-710-10Product
13811-710-30Product
Class III Terminated
Subpotent Drug
Dec 18, 2017
Dec 27, 2017
10064 bottles
Recall Profile & Regulatory Data
Event ID
78764
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Osmotica Pharmaceutical Corp
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 01, 2019
Product Description
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10
Batch or Lot Expiration Information
Lot# : 170027A, Exp. 02/2019
Affected Packages Involved in this Recall
13811-709-10Product
13811-706-10Product
13811-707-10Product
13811-708-10Product
13811-710-10Product
13811-710-30Product
Class III Terminated
Subpotent Drug
Dec 18, 2017
Dec 27, 2017
9919 bottles
Recall Profile & Regulatory Data
Event ID
78764
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Osmotica Pharmaceutical Corp
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 01, 2019
Product Description
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
Batch or Lot Expiration Information
Lot# : 170029A, Exp. 02/2019; 170030A, Exp. 02/2019
Affected Packages Involved in this Recall
13811-709-10Product
13811-706-10Product
13811-707-10Product
13811-708-10Product
13811-710-10Product
13811-710-30Product
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.
