Trigen Laboratories recalls 36mg methylphenidate extended-release tablets (NDC 13811-708-10) because this batch failed dissolution tests. No remedy is specified in the recall notice.
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Trigen Laboratories is recalling a specific batch of 36mg methylphenidate extended-release tablets due to failure in dissolution testing. This means the tablets may not release medication properly, potentially affecting treatment effectiveness.
The tablets failed dissolution specifications, meaning they may not release medication at the intended rate. This could lead to inconsistent dosing or reduced effectiveness of the medication over time.
Prescription users who received this specific batch (NDC 13811-708-10, Lot 230159M) from Trigen Laboratories. People with ADHD or other conditions requiring methylphenidate are most at risk of improper medication delivery.
Check for the product name 'Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle' with NDC 13811-708-10 and lot number 230159M. This batch was manufactured by Trigen Laboratories in Alpharetta, GA.
Identify the NDC code 13811-708-10 and lot number 230159M on the packaging.
The recall states the batch failed dissolution specifications, but no specific safety risks are mentioned. The product may not release medication properly, potentially affecting treatment effectiveness.
The recall notice does not specify a remedy, so no action is required beyond checking if you have the recalled batch.
The recall does not mention any risk of serious injury; it focuses on potential treatment ineffectiveness due to failed dissolution testing.
We’ve drafted a message you can send Trigen to request your refund or repair — edit it as you like.
Subject: Recall D-0579-2024 — Trigen Trigen Hello, I own a Trigen that is covered by recall D-0579-2024 from Trigen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
