Recalling firm
Trigen Laboratories
Product type
Drug
Status
Terminated
Report date
2024-07-10
Distribution
Nationwide in the USA
Firm state
GA
Product quantity
10,448 100-count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
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
Code / lot info
Lot 230159M, Exp Date 2/28/2026
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.