D-0608-2026Class III

Sandoz Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Sandoz Inc

Product type

Drug

Status

Ongoing

Report date

2026-06-24

Distribution

U.S. Nationwide

Firm state

Product quantity

7,803 bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date

Product description

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

Code / lot info

Lot VA0099422; Exp. Date June 30, 2028

Other recalls SPEQ maps to Documentation & Change Control

2026-09-02Class IIMidmark Corporation 2026-09-02Class IIConMed Corporation 2026-09-02Class IIAVID Medical, Inc.2026-09-02Class IIOlympus Corporation of the Americas

See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →