Focalin XR Recall Due to Labeling Issue
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Sandoz Inc is voluntarily recalling 7,803 bottles of Focalin XR (dexmethylphenidate HCl) 5 mg due to incorrect or missing lot and expiration date labeling.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 1, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Sandoz Inc initiated a voluntary recall of Focalin XR after discovering labeling errors involving incorrect or missing lot and expiration date information.
Which Products Are Affected
The recall covers Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, NDC 66758-235-31. Affected units are from Lot VA0099422 with an expiration date of June 30, 2028. A total of 7,803 bottles are involved in the U.S. Nationwide distribution.
What You Should Do
Consumers should check their medication bottles for the affected lot number and contact Sandoz Inc or their pharmacist for return or refund instructions.
Why This Matters
This Class III recall addresses a labeling defect on a prescription medication distributed across the United States.
Source
FDA recall number D-0608-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (843 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to August 1, 2026.
Frequently Asked Questions
Common questions about this FDA recall.