Methylphenidate Hydrochloride Oral Solution 5mg per 5mL

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Presence of Foreign Substance; Fiber particles.

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

What was recalled

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.

Affected NDC 10702-0163-50

Compare with the code on your package — it is the most precise check available.

Drug: Alcohol

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

Product	Strength	Form & route	Labeler	Type
Methylphenidate Methylphenidate Hydrochloride NDC 10702-0163	5 mg/5mL	Solution Oral	KVK-Tech, Inc.	Rx · CII

Recalling firm: KVK-Tech, Inc.
NDC code: 10702-0163-50
Origin: PA, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0142-2020 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.