June 2024 FDA Recall Methylphenidate Hydrochloride by Trigen Laboratories
D-0579-2024 - Failed dissolution specifications

This Class II drug recall was voluntarily initiated by Trigen Laboratories on June 17, 2024 for the product Methylphenidate Hydrochloride. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0579-2024

Reason for Recall
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Initiated
06-17-2024
Reported
07-10-2024
Quantity
10,448 100-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94818
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Trigen Laboratories
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-23-2025
Product Description About Product Description
Full technical description of the product.
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

13811-709-10 Methylphenidate Hydrochloride
13811-706-10 Methylphenidate Hydrochloride
13811-707-10 Methylphenidate Hydrochloride
13811-708-10 Methylphenidate Hydrochloride
13811-710-10 Methylphenidate Hydrochloride
13811-710-30 Methylphenidate Hydrochloride