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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

KVK-Tech, Inc.: Methylphenidate Hydrochloride Oral Solution Recalled for Fiber Particles

Agency Publication Date: October 15, 2019
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Summary

KVK-Tech, Inc. is recalling 384 bottles of Methylphenidate Hydrochloride Oral Solution (the generic version of Ritalin), 5mg per 5mL. This recall was initiated because fiber particles were found in the solution, which is a foreign substance that should not be present in medication. Consumers who have this prescription drug should be aware that it was distributed in 500 mL bottles nationwide across the United States.

Risk

The presence of foreign fiber particles in an oral medication can pose a risk of irritation or injury to the digestive tract or other internal tissues if swallowed. While the risk level is currently classified as low, foreign substances can compromise the safety and purity of the medication.

What You Should Do

  1. Check your medication bottle to see if it is Methylphenidate Hydrochloride Oral Solution 5mg per 5mL in a 500 mL bottle with NDC 10702-0163-50.
  2. Locate the batch and expiration information on the label to see if it matches Batch # 15315A with an expiration date of 02/2021.
  3. If your bottle matches this batch, contact your healthcare provider or pharmacist immediately for guidance on your treatment and to report the issue.
  4. Return any unused portion of the affected medication to your pharmacy to receive a refund.
  5. Contact the manufacturer, KVK-Tech, Inc., for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare consultation and pharmacy return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Methylphenidate Hydrochloride Oral Solution 5mg per 5mL (500 mL Bottle)
Model:
NDC 10702-0163-50
Recall #: D-0142-2020
Lot Numbers:
15315A (Exp. 02/2021)
Date Ranges: 02/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83851
Status: Resolved
Manufacturer: KVK-Tech, Inc.
Sold By: pharmacies
Manufactured In: United States
Units Affected: 384 bottles
Distributed To: Nationwide

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 · 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.