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FDA · Drugs ·

Focalin XR (dexmethylphenidate HCl) 5 mg recall

Sandoz Inc recalled Focalin XR (dexmethylphenidate HCl) 5 mg on June 24, 2026 because of labeling: Incorrect or Missing Lot and/or Exp Date. It was sold nationwide.

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp Date

What's recalled

Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31

Quantity: 7,803 bottles

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Sandoz Inc, Princeton, NJ
Date
Severity
Class III
the product is unlikely to cause health problems but breaks a rule.
Where sold
Nationwide
U.S. Nationwide
Status
Ongoing
Recall number
D-0608-2026
Source
U.S. Food and Drug Administration

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