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Low risk

The FDA considers this unlikely to cause harm. Return it for a refund if you would rather not keep it.

Class III

  • Unlikely to cause any adverse health consequence, but the product breaks FDA rules.
  • Refunds don't require a receipt, and you don't need proof of purchase.
  • FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14
Low risk Filed 2026-06-24

Labeling: Incorrect or Missing Lot and/or Exp Date

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

Check these codes: Lot VA0099422; Exp. Date June 30, 2028

7,803 bottles · distributed u.s. nationwide Recall D-0608-2026 on FDA.gov ↗
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