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Use caution Drug recall · FDA · Published October 4, 2019

KVK-Tech Recalls Methylphenidate Oral Solution Due to Foreign Particles

KVK-Tech recalls 384 bottles of Methylphenidate Hydrochloride Oral Solution due to fiber particles. Check your batch and expiration date.

🇺🇸 FDA recall #D-0142-2020DrugKVK-Tech ›
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Recalling firmKVK-Tech, Inc.110 Terry Dr · Newtown, PA 18940-3427
✎ GovInfoNow plain-language explainer

KVK-Tech, Inc. is recalling one lot of Methylphenidate Hydrochloride Oral Solution because it may contain foreign substance, specifically fiber particles. The recall affects 384 bottles distributed nationwide in the U.S. This product is a prescription-only medication. Read more at govinfonow.com/recall/37870-kvk-tech-recalls-methylphenidate-oral-solution-due-to-foreign-particles.

Source Summary by GovInfoNow · govinfonow.com/recall/37870-kvk-tech-recalls-methylphenidate-oral-solution-due-to-foreign-particles · Updated October 11, 2026 · FDA enforcement record: FDA #D-0142-2020

Cite this page

“KVK-Tech Recalls Methylphenidate Oral Solution Due to Foreign Particles.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37870-kvk-tech-recalls-methylphenidate-oral-solution-due-to-foreign-particles. Based on FDA recall #D-0142-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0142-2020%22&limit=1).

The FDA announced on Oct. 4, 2019, that KVK-Tech, Inc. voluntarily recalled Methylphenidate Hydrochloride Oral Solution due to the presence of foreign fiber particles. The recall affects 384 bottles distributed nationwide.

How to tell if you have it

  • Brand: KVK-Tech
  • Product: Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free
  • NDC: 10702-0163-50
  • Batch #: 15315A
  • Expiration Date: 02/2021
  • Manufacturer: KVK Tech, Inc., Newtown, PA 18940

The hazard

The product contains foreign fiber particles. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show KVK Tech, Inc. has 11 other recalls on record since Dec. 11, 2013. Other recent recalls of similar products include Taro Recalls Children's Ibuprofen Due to Foreign Substance (March 2, 2026), Heritage Pharma Recalls Clindamycin Oral Solution Due to Foreign Particles (July 30, 2026), and ANI Pharmaceuticals recalls hydrOXYzine oral solution due to foreign substance (June 2, 2026).

How to tell if you have this one

Check if you have Methylphenidate Hydrochloride Oral Solution 5mg per 5mL in a 500 mL bottle. Verify the label reads 'Sugar Free Alcohol Free, Rx Only' and is manufactured by KVK Tech, Inc. Look for Batch # 15315A with an expiration date of 02/2021 and NDC 10702-0163-50.

  • Brand
    KVK-Tech
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Medication

    Verify if your bottle matches Batch # 15315A and has an expiration date of 02/2021.

  2. Contact Your Pharmacist

    Speak with your healthcare provider or pharmacist to determine the appropriate next steps for this recalled prescription.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

1. Firm started the recall: Oct 4, 201912. FDA classified it Class III: Oct 15, 201923. Published in FDA’s Enforcement Report: Oct 23, 201934. FDA terminated the recall: Apr 20, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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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-0142-2020 (October 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0142-2020 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA