Osmotica Pharmaceutical Corp recalls Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC
Osmotica recalls 36mg Methylphenidate ER tablets due to subpotent drug content. Affected lots: 170231B-170234A. Consumers should contact pharmacy for replacement.
Lower-risk recall
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Contact the company & request your remedy
What happened, in plain English
Osmotica is recalling 36mg Methylphenidate Hydrochloride Extended-release Tablets that contain less active ingredient than labeled. This means the medication may not work as intended for patients needing treatment. Read more at govinfonow.com/recall/40797-osmotica-methylphenidate-tablets-36mg-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40797-osmotica-methylphenidate-tablets-36mg-recall-subpotent-drug-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0581-2018
Cite this page
“Osmotica Methylphenidate Tablets 36mg Recall: Subpotent Drug Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40797-osmotica-methylphenidate-tablets-36mg-recall-subpotent-drug-risk. Based on FDA recall #D-0581-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0581-2018%22&limit=1).
Why it’s dangerous
The recalled tablets contain only 27mg of active ingredient instead of the labeled 36mg. This subpotent content means the medication may not provide the intended therapeutic effect for patients.
Who’s affected
Patients prescribed methylphenidate for ADHD or similar conditions who have the specific lot numbers. Those using the product without a prescription are not affected.
How to tell if you have this one
Check for the product name 'Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg' on the label. Look for lot numbers 170231B, 170232A, 170233A, or 170234A on the bottle.
- Brand
Osmotica- Category
Drug
What to do — step by step
Contact Pharmacy
Reach out to your pharmacy to get a replacement product with the correct dosage.
Questions people ask
Why is this product being recalled?
The product contains less active ingredient than labeled, which may result in reduced effectiveness.
Do I need to stop using this product?
No, but you should contact your pharmacy for a replacement with the correct dosage.
What lot numbers are affected?
Lots 170231B, 170232A, 170233A, and 170234A.
Contact Osmotica
We’ve drafted a message you can send Osmotica to request your refund or repair — edit it as you like.
Subject: Recall D-0581-2018 — Osmotica Osmotica Hello, I own a Osmotica that is covered by recall D-0581-2018 from Osmotica. 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-0581-2018 (February 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0581-2018 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.