Osmotica Pharmaceutical Corp recalls Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories,
Osmotica Pharmaceutical Corp recalls 27mg methylphenidate tablets due to subpotent drug levels. Affected products have NDC 13811-707-10 and lot 170027A. No remedy specified in recall notice.
Recall notice
Subpotent Drug
Contact the company & request your remedy
What happened, in plain English
Osmotica Pharmaceutical Corp is recalling 27mg methylphenidate hydrochloride extended-release tablets that may contain less active ingredient than labeled. This could lead to inadequate treatment for ADHD or other conditions requiring the medication. Read more at govinfonow.com/recall/41010-osmotica-methylphenidate-tablets-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41010-osmotica-methylphenidate-tablets-recall-subpotent-drug-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0110-2018
Cite this page
“Osmotica Methylphenidate Tablets Recall: Subpotent Drug Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41010-osmotica-methylphenidate-tablets-recall-subpotent-drug-risk. Based on FDA recall #D-0110-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0110-2018%22&limit=1).
Why it’s dangerous
Subpotent drug means the tablets contain less active medication than labeled. This could result in the medication not working effectively for ADHD treatment. Patients might need higher doses than intended, potentially causing treatment failure.
Who’s affected
Prescription users of ADHD medication who received the specific 27mg tablets with NDC 13811-707-10 and lot 170027A. Patients with uncontrolled ADHD symptoms may be at higher risk.
How to tell if you have this one
Check for NDC code 13811-707-10 and lot number 170027A on the product label. These tablets are prescription-only and sold by Trigen Laboratories in Bridgewater, NJ.
- Brand
Osmot: Trigen Laboratories- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide- NDC
13811-709-10, 13811-706-10, 13811-707-10, 13811-708-10, 13811-710-10, 13811-710-30
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0110-2018 | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10; Lot #: 170027A, Exp. 02/2019 | 10064 bottles |
| D-0111-2018 | Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10; Lot #: 170029A, Exp. 02/2019; 170030A, Exp. 02/2019 | 9919 bottles |
What to do — step by step
Check Product Label
Look for NDC 13811-707-10 and lot number 170027A on the tablet packaging.
Questions people ask
Why is this medication being recalled?
The recall is for subpotent drug levels, meaning the tablets may contain less active medication than labeled.
What should I do if I have these tablets?
The recall notice does not specify a remedy, so contact your healthcare provider for advice.
Are there any safety risks from using these tablets?
The recall indicates potential treatment failure, but no specific safety risks like injury are mentioned.
Contact Osmot: Trigen Laboratories
We’ve drafted a message you can send Osmot: Trigen Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0110-2018 — Osmot: Trigen Laboratories Osmot: Trigen Laboratories Hello, I own a Osmot: Trigen Laboratories that is covered by recall D-0110-2018 from Osmot: Trigen Laboratories. 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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Where this comes from
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.
- Official source: FDA Recall #D-0110-2018 (December 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0110-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.