Drug FDA Class II Terminated Failed specifications

Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10

Trigen Laboratories Published Jul 10, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Trigen Laboratories or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

Failed Dissolution · primary

Affected products (1)

Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10

METHYLPHENIDATE HYDROCHLORIDE · 10,448 100-count bottles

NDC: 13811-706, 13811-709, 13811-707, 13811-708, 13811-710, 13811-709-10, 13811-706-10, 13811-707-10, 13811-708-10, 13811-710-10, 13811-710-30

Lot codes: 230159M

Code info: Lot 230159M, Exp Date 2/28/2026

Affected areas

Nationwide

Timeline

Initiated

Jun 17, 2024
Published

Jul 10, 2024
Terminated

Sep 23, 2025

Recall number: D-0579-2024
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.