FDAClass IIJuly 10, 2024

Methylphenidate Hydrochloride recall: Failed Dissolution

Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta…

Why was Methylphenidate Hydrochloride recalled?

Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 230159M, Exp Date 2/28/2026

Product
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta…
Recalling firm
Trigen Laboratories
Quantity
10,448 100-count bottles
Distribution
Nationwide in the USA
Recall date
July 10, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls