Methylphenidate Hydrochloride recall
FDA recall D-0579-2024 · initiated Jun 17, 2024
Trigen Laboratories recalled Methylphenidate Hydrochloride in Jun 2024 — an FDA Class II recall (D-0579-2024) because Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 10,448 100-count bottles
Details
- Product
- Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
- Recalling company
- Trigen Laboratories
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jun 17, 2024
- FDA report date
- Jul 10, 2024
Frequently asked
- Was Methylphenidate Hydrochloride recalled?
- Trigen Laboratories recalled Methylphenidate Hydrochloride in Jun 2024 — an FDA Class II recall (D-0579-2024) because Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Methylphenidate Hydrochloride recalled?
- Per the FDA enforcement record, the reason for recall D-0579-2024 was: Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
- Is a recalled Methylphenidate Hydrochloride dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Methylphenidate Hydrochloride are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot 230159M, Exp Date 2/28/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0579-2024.