Recall: D-0579-2024

Class II - Potentially Harmful

Class IIClassification

2024-06-17Initiated

TerminatedStatus

Trigen LaboratoriesFirm

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

Reason

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.