KVK-Tech Methylphenidate Hydrochloride Oral Solution Recall

Why it was recalled

Presence of Foreign Substance; Fiber particles.

Product description

Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.

Lot numbers, UPCs & expiration codes

Batch # 15315A, Exp. 02/2021

Where it was sold

Nationwide in the U.S.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0142-2020
Classification: Class III
Status: Terminated
Recall initiated: Oct 4, 2019
FDA report date: Oct 23, 2019
Quantity: 384 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: KVK-Tech, Inc.

Original FDA data

Every field from FDA enforcement report D-0142-2020, exactly as published.

Show all FDA fields

City: Newtown
State: PA
Status: Terminated
Country: United States
Event ID: 83851
Address: 110 Terry Dr
Code information: Batch # 15315A, Exp. 02/2021
Postal code: 18940-3427
Report date: Oct 23, 2019
Product type: Drugs
Recall number: D-0142-2020
Classification: Class III
Recalling firm: KVK-Tech, Inc.
Product quantity: 384 bottles
Termination date: Apr 20, 2020
Reason for recall: Presence of Foreign Substance; Fiber particles.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.
Distribution pattern: Nationwide in the U.S.
Recall initiation date: Oct 4, 2019
Initial firm notification: Letter
Center classification date: Oct 15, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0142-2020, published Oct 23, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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