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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Methylphenidate Hydrochloride ER Tablets Recalled for Dissolution Issues

Agency Publication Date: July 2, 2024
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Summary

Trigen Laboratories is recalling approximately 10,448 100-count bottles of Methylphenidate Hydrochloride (the generic version of Concerta) 36mg Extended-release Tablets. The medication is being recalled because it failed dissolution specifications during testing. This means the tablets may not release the active ingredient into the body at the correct speed or concentration, which could affect the drug's performance.

Risk

If the medication does not dissolve as intended, a patient might receive too much or too little of the drug at one time. This could lead to a lack of effectiveness in managing ADHD symptoms or an increased risk of side effects from the stimulant medication.

What You Should Do

  1. The recalled product is Methylphenidate Hydrochloride, Extended-release Tablets, 36mg, sold in 100-count bottles under NDC 13811-708-10. Affected bottles are labeled with lot 230159M and an expiration date of 2/28/2026.
  2. If you have health concerns regarding this medication, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Trigen Laboratories for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg (100-count Bottle)by Trigen Laboratories
Variants: 36mg, Extended-release, Tablet
Lot Numbers:
230159M (Exp 2/28/2026)
NDC:
13811-708-10

Rx Only; Recall #: D-0579-2024; Quantity: 10,448 bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94818
Status: Resolved
Manufacturer: Trigen Laboratories
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 10,448 100-count bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.